Endoluminal prosthesis having multiple branches or fenestrations and methods of deployment

ABSTRACT

A system for facilitating deployment of an endoluminal prosthesis may include a main tubular graft body including a proximal end opening, a distal end opening, a lumen, and a sidewall. A branch may extend from the sidewall and may include a first end opening, a second end opening, and a lumen. A fenestration may be disposed in the sidewall and positioned distal of the second end opening of the branch. A wire segment may include a proximal portion positioned proximal of the proximal end opening and a distal portion positioned distal of the distal end opening. The wire segment extend through the fenestration and through the lumen of the branch in a preloaded configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

The patent application is a continuation of application Ser. No.13/457,092, filed Apr. 26, 2012, which claims priority and the benefitof provisional U.S. Patent Application Ser. No. 61/480,091, filed Apr.28, 2011, provisional U.S. Patent Application Ser. No. 61/526,061, filedAug. 22, 2011, and provisional U.S. Patent Application Ser. No.61/581,475, filed Dec. 29, 2011, all of which are incorporated herein byreference in their entirety.

TECHNICAL FIELD

This disclosure relates to endoluminal medical devices for implantationwithin the human or animal body for treatment of endovascular disease.

BACKGROUND

The present disclosure relates generally to medical devices. Moreparticularly, it relates to an endoluminal prosthesis having multiplebranches or fenestrations and systems and methods for facilitatingdeployment of such an endoluminal prosthesis.

Using stent grafts to treat aneurysms is common in the medical field.Stent grafts are deployed by accessing a vasculature with a smallincision in the skin and guiding a delivery system to the target area.This intraluminal delivery is less invasive and generally preferred overmore intrusive forms of surgery. Multiple stent grafts may be implantedusing intraluminal delivery to provide a system of interconnected stentgrafts. Interconnected stent grafts can be made of fenestrated stentgrafts and smaller side branch grafts, including bifurcated components.

Sometimes aneurysms engulf a vessel and its branch vessels, such as theaorta and the renal arteries or the aortic arch and the branch arteries.In such instances, a fenestrated graft can be implanted in the mainvessel while smaller branch grafts can be deployed in the brancharteries. The main vessel grafts have fenestrations that correspond withthe openings of the branch vessels. The smaller branch grafts are joinedwith the main vessel graft at the fenestrations. Due to the torsion andrigors of the endovascular system, this juncture can be subject tosignificant stress.

Moreover, when a condition such as an aneurysm has engulfed a mainvessel and multiple branch vessels, it may be relatively time consumingto deliver the smaller branch grafts needed in addition to the maingraft. For example, insertion of wire guides and delivery devices may betime consuming and/or difficult to perform when multiple smaller branchgrafts are deployed to cannulate multiple corresponding branch vessels.

SUMMARY

The present embodiments provide an endoluminal prosthesis havingmultiple branches or fenestrations and systems and methods forfacilitating deployment of such an endoluminal prosthesis.

In one example, a system for facilitating deployment of an endoluminalprosthesis may include a main tubular graft body of a biocompatiblematerial. The main tubular graft body may include a proximal endopening, a distal end opening, a lumen extending longitudinally betweenthe proximal end opening and the distal end opening, and a sidewall. Abranch may extend from the sidewall of the main tubular graft body. Thebranch may include a first end opening, a second end opening, and alumen extending between the first end opening and the second end openingof the branch. A fenestration may be disposed in the sidewall andpositioned distal of the second end opening of the branch. The systemmay include a wire segment including a proximal portion positionedproximal of the proximal end opening of the main tubular graft body anda distal portion positioned distal of the distal end opening of the maintubular graft body. The wire segment may extend through the fenestrationand through the lumen of the branch in a preloaded configuration.

In another example, a system for treating a damaged body vessel mayinclude a delivery device, an endoluminal prosthesis, and a wiresegment. The delivery device may include a cannula including a guidewire lumen extending longitudinally within the cannula. The deliverydevice may include a catheter including a lumen extending longitudinallywithin the catheter. The cannula may be received within the lumen of thecatheter. The delivery device may include an auxiliary sheath receivedwithin the lumen of the catheter and including a lumen extendinglongitudinally within the auxiliary sheath. The delivery device mayinclude a length extending module extending from a proximal end of thecannula. The length extending module may be releasably coupled to thecannula. The prosthesis may be positioned on the cannula of the deliverydevice. The prosthesis may include a main tubular graft body includingan open proximal end, an open distal end, a lumen extendinglongitudinally within the main tubular graft body and in fluidcommunication with each of the open proximal end and the open distalend, and a sidewall. The cannula of the delivery device may be receivedwithin the lumen of the main tubular graft body and each of the openproximal end and the open distal end. The prosthesis may include a firstfenestration in the sidewall and a second fenestration in the sidewall.The second fenestration may be positioned distal of the firstfenestration. The wire segment may extend within the lumen of theauxiliary sheath and through each of the first fenestration and thesecond fenestration of the prosthesis. A proximal end of the wiresegment may be positioned near a proximal end of the length extendingmodule. A distal end of the wire segment may be positioned distal of thedistal end of the main tubular graft body.

In another example, a method of treating a damaged body vessel mayinclude introducing a prosthesis endoluminally into the body vessel on adelivery device. The delivery device may include a tubular cannula. Adilator tip may be positioned at a proximal end of the cannula. A lengthextending module may extend from a proximal end of the dilator tip. Acatheter may surround a portion of the cannula and include a lumenextending longitudinally within the catheter. The method may includesevering an auxiliary guide wire to separate a first wire segment of theauxiliary guide wire from a second wire segment of the auxiliary guidewire. The method may include removing the length extending module fromthe dilator tip. The method may include tracking a first introducer in adistal to proximal longitudinal direction over the first wire segmentand through a preloaded auxiliary sheath positioned within the lumen ofthe catheter to deploy a first delivery component in a fenestration ofthe prosthesis. The method may include tracking a second introducer in aproximal to distal longitudinal direction over the first wire segment todeploy a second delivery component in a branch of the prosthesis.

Other systems, methods, features, and advantages of the invention willbe, or will become, apparent to one with skill in the art uponexamination of the following figures and detailed description. It isintended that all such additional systems, methods, features, andadvantages be. within the scope of the invention, and be encompassed bythe following claims.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1 is a side view of one embodiment of an endoluminal prosthesis ina preloaded configuration.

FIG. 2 is a perspective view of the endoluminal prosthesis of FIG. 1.

FIG. 3 depicts one embodiment of a pivot fenestration.

FIG. 4 is a partial, cross sectional view of a portion of one embodimentof a prosthesis having a pivot fenestration.

FIG. 5 is an interior view of one embodiment of a pivot fenestration.

FIG. 6 is an exterior view of the pivot fenestration of FIG. 5.

FIG. 7 depicts a prosthesis having a protrusion of graft material toform one embodiment of a pivot fenestration.

FIG. 8 is a side view of another embodiment of an endoluminal prosthesisin a preloaded configuration.

FIG. 9 is a perspective view of the endoluminal prosthesis of FIG. 8.

FIG. 10A is a perspective view of one embodiment of a delivery device.

FIG. 10B is a perspective view of the delivery device of FIG. 10A with asheath retracted to expose an endoluminal prosthesis retained on thedelivery device.

FIG. 10C is a transverse cross-sectional view of the delivery devicetaken along line 10C-10C′ of FIG. 10A.

FIG. 10D is a partial perspective view of the proximal end of a pushercatheter of the delivery device of FIG. 10A.

FIG. 11 is a perspective view of a proximal portion of the deliverydevice of FIG. 10A.

FIG. 11A is a transverse cross-sectional view of the delivery devicetaken along line 11A-11A′ of FIG. 11.

FIG. 11B is a transverse cross-sectional view of the delivery devicetaken along line 11B-11B′ of FIG. 11.

FIG. 11C depicts one embodiment of a longitudinal groove of a deliverydevice.

FIG. 11D depicts another embodiment of a longitudinal groove of adelivery device.

FIG. 11E is a transverse cross-sectional view of the delivery devicetaken along line 11E-11E′ of FIG. 11.

FIG. 11F is a transverse cross-sectional view of the delivery devicetaken along line 11F-11F′ of FIG. 11.

FIG. 11G is a partial perspective view of a proximal portion of oneembodiment of a length extending module of a delivery device.

FIG. 11H is a transverse cross-sectional view of the delivery devicetaken along line 11H-11H′ of FIG. 11G.

FIG. 11I is a transverse cross-sectional view of the delivery devicetaken along line 11I-11I′ of FIG. 11G.

FIG. 12A depicts one embodiment of a connection arrangement between anose cone dilator and a length extending module of a delivery device.

FIG. 12B depicts another embodiment of a connection arrangement betweena nose cone dilator and a length extending module of a delivery device.

FIG. 12C depicts another embodiment of a connection arrangement betweena nose cone dilator and a length extending module of a delivery device.

FIG. 12D depicts another embodiment of a connection arrangement betweena nose cone dilator and a length extending module of a delivery device.

FIG. 13A is a partial perspective view of one embodiment of a deliverydevice having a nose cone dilator and a length extending module.

FIG. 13B is a partial longitudinal cross-sectional view of theconnection arrangement between the nose cone dilator and the lengthextending module of FIG. 13A.

FIG. 14A illustrates an exemplary method step of introducing a guidewire and a brachial access sheath into the vasculature of a patient.

FIG. 14B illustrates an exemplary method step of engaging the guide wirewith a grasper device and a snare.

FIG. 14C shows the guide wire extending through the brachial accesssheath.

FIG. 14D illustrates an exemplary method step of tracking a deliverydevice over the guide wire.

FIG. 14E shows the delivery device with a length extending moduleremoved and auxiliary wire segments extending from the brachial accesssheath.

FIG. 14F illustrates an exemplary method step of retracting a sheath ofthe delivery device to expose an endoluminal prosthesis in an aorta ofthe patient.

FIGS. 15A-15C illustrate exemplary method steps of the cannulation ofeach of a celiac artery and a left renal artery of the patient.

FIGS. 15D-15F illustrate exemplary method steps of deploying a sidebranch prosthesis in each of a branch and a fenestration of theendoluminal prosthesis of FIG. 1.

FIG. 15G shows the endoluminal prosthesis of FIG. 1 deployed within theaorta of the patient.

FIG. 16 illustrates a branch prosthesis deployed in a left branchvessel, where the left branch vessel is positioned lower than thecorresponding right branch vessel.

FIG. 17 illustrates a branch prosthesis deployed in a left branchvessel, where the left branch vessel is positioned higher than thecorresponding right branch vessel.

FIG. 18A illustrates the endoluminal prosthesis of FIG. 8 positionedwithin a thoracoabdominal aorta of a patient.

FIGS. 18B-18E illustrate exemplary method steps for deploying a branchprosthesis within one branch of the endoluminal prosthesis of FIG. 8.

FIGS. 18F-18G illustrate exemplary method steps for deploying a branchprosthesis within another branch of the endoluminal prosthesis of FIG.8.

FIGS. 18H-18J illustrate exemplary method steps for deploying a branchprosthesis within another branch of the endoluminal prosthesis of FIG.8.

FIGS. 18K-18L illustrate exemplary method steps for deploying a branchprosthesis within another branch of the endoluminal prosthesis of FIG.8.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

The present disclosure relates to an endoluminal prosthesis havingmultiple branches or fenestrations and systems and methods forfacilitating deployment of such an endoluminal prosthesis. A side branchprosthesis may be deployed within each of the branches and/orfenestrations of the endoluminal prosthesis to enable fluid to flow fromthe endoluminal prosthesis into the branch vessels. The fenestrationsmay be configured as pivot fenestrations that are capable of pivoting asneeded to accommodate the dynamic geometry of the branch vessels, suchas the aortic branches. For example, in various aspects shown anddescribed in more detail below, one or more pivot fenestrations of anendoluminal prosthesis may lie outside the surface plane of the body ofthe prosthesis. The pivot fenestration may allow a side branchprosthesis (e.g., a stent, a graft, or a stent-graft) deployed in thepivot fenestration to pivot into a variety of orientations to facilitatemeeting and sealing of the side branch prosthesis with the branchvessel. The orientation of the pivot fenestrations may dynamicallychange over time to conform to changing anatomy.

In the present disclosure, the term “proximal” refers to a directionthat is generally closest to the heart during a medical procedure, whilethe term “distal” refers to a direction that is farthest from the heartduring a medical procedure.

The term “fenestration” refers to an opening provided through a surfaceof a prosthesis from the interior of the prosthesis to the exterior ofthe prosthesis. A fenestration may have a variety of geometriesincluding circular, semi-circular, oval, oblong, or other geometries.

FIGS. 1-2 depict one embodiment of a prosthesis 110, which may beconfigured as a stent graft. The prosthesis 110 may include a graft 112which forms a main body of the prosthesis 110. The graft 112 may includea generally tubular body of a biocompatible material. The graft 112 mayhave a proximal end 118, a distal end 119, and a lumen 120 extendinglongitudinally within the graft 112 between the proximal end 118 and thedistal end 119. The lumen 120 may be configured to enable a body fluid(e.g., blood) to flow from the proximal end 118 to the distal end 119 ofthe graft 112.

Many different types of graft materials may be used for the graft 112.The biocompatible material of the graft 112 may be substantiallynon-toxic in the in vivo environment of its intended use, and may besubstantially unrejected by the patient's physiological system (i.e., isnon-antigenic). Examples of biocompatible materials from which textilegraft material can be formed include, without limitation, polyesters,such as polyethylene terephthalate; fluorinated polymers, such aspolytetrafluoroethylene (PTFE) and fibers of expanded PTFE (ePTFE), andpolyurethanes. In addition, materials that are not inherentlybiocompatible may be subjected to surface modifications to render thematerials biocompatible. Examples of surface modifications include, forexample, graft polymerization of biocompatible polymers on the surface,coating of the surface with a crosslinked biocompatible polymer,chemical modification with biocompatible functional groups, andimmobilization of a compatibilizing agent such as heparin or otherbiocompatible substances. Thus, any fibrous material having sufficientstrength to survive in the in vivo environment may be used to form atextile graft, provided the final textile is biocompatible.

In addition to the polyesters, fluorinated polymers, and polyurethanesdescribed above, fibers suitable for making textile grafts include, forexample, polyethylene, polypropylene, polyaramids, polyacrylonitrile,nylon, and cellulose. Bioremodelable materials also may be used singlyor in combination with the aforementioned polymer materials. The textilemay be made of one or more polymers that do not require treatment ormodification to be biocompatible. The graft 112 may be constructed fromwoven multifilament polyester such as, for example and withoutlimitation, Dacron™, commercially available from E. I. DuPont de Nemoursand Co., Wilmington, Del. Dacron™ is known to be sufficientlybiologically inert, non-biodegradable, and durable to permit safeinsertion inside the human body. The graft 112 also may be made fromnatural or organic materials, for example and without limitation, abiological scaffold or bioremodelable material, such as small intestinesubmucosa (“SIS”), commercially available from Cook Medical Inc.,Bloomington, Ind. The graft 112 may be formed from a single layer ormultiple layers of material. In embodiments employing a plurality oflayers of material, the layers may remain separate, or may be attachedto one another through a secondary process such as sintering, curing,adhesives, sutures, or the like.

The prosthesis 110 may include at least one stent 114 coupled to thegraft 112. In the embodiment of FIGS. 1-2, a plurality of internalstents 114 a are coupled to an inner surface 121 of the graft 112 alonga proximal region of the graft, while a plurality of external stents 114b are coupled to an outer surface 122 of the graft along a distal regionof the graft. While one exemplary arrangement is shown in FIGS. 1-2, itwill be appreciated that each of the stents 114 may be coupled to innerand/or outer surfaces of the graft 112. An internal stent 114 a may beconfigured as a sealing stent and may be placed at or near the proximalend 118 of the graft 112 to seal the graft at the proximal end to thewall of a body vessel (e.g., a blood vessel) into which the prosthesis110 may be placed. Additionally, or alternatively, depending on thelocation where the prosthesis 110 is placed or a particular need, asealing stent may be placed at either or both the proximal end 118and/or the distal end 119 of the graft 112.

Stents may add rigidity, expansion force, and/or support to theprosthesis. A stent may be used to obtain and maintain the patency of abody passageway while maintaining the integrity of the passageway. Thestents 114 may be made from numerous metals and alloys. For example, thestents 114 may be made from a metallic material selected from stainlesssteel, silver, platinum, palladium, gold, titanium, tantalum, iridium,tungsten, cobalt, chromium, cobalt-chromium alloy 1058, cobalt-based 35Nalloy, nickel-based alloy 625, a molybdenum alloy, a molybdenum alloyincluding about 0.4% to about 0.8% of lanthanum oxide (Li₂O₃), and anickel-titanium alloy, such as nitinol, or other suitable materialsknown in the art. In one example, the stents 114 may include ashape-memory material such as nitinol. Moreover, the structure of thestents 114 may be formed in a variety of ways to provide a suitableintraluminal support structure. For example, one or more stents may bemade from a woven wire structure, a laser-cut cannula, individualinterconnected rings, or another pattern or design.

In one example, shown in FIGS. 1-2, the stents 114 may be configured inthe form of one or more “Z-stents” or Gianturco stents, each of whichmay include a series of substantially straight segments interconnectedby a series of bent segments. The bent segments may include acute bendsor apices. The Gianturco stents are arranged in a zigzag configurationin which the straight segments are set at angles relative to one anotherand are connected by the bent segments. However, as noted above, thestents 114 may be configured in any suitable configuration, and one ormore stents may be provided.

The prosthesis 110 may include a plurality of openings. Each opening maybe configured as a branch, a fenestration, or any other type of openingformed in the graft 112. The lumen 120 of the graft 112 may be incommunication with a point external of the graft through the opening. Inone embodiment, the prosthesis 110 may include four openings includingtwo branches and two fenestrations as shown in FIGS. 1-2. For example,the prosthesis 110 may include a first branch 130 having a proximalregion 132, a distal region 134, and a lumen 135 extending therebetween.The first branch 130 may extend radially outward from the graft 112, asshown in FIGS. 1-2. The proximal region 132 of the first branch 130 maybe configured as a proximal end opening, which may be in fluidcommunication with a fenestration in the graft 112. In this manner, thelumen 135 of the first branch 130 may be in fluid communication with thelumen 120 of the graft 112 through the fenestration. The lumen of anyother branch described herein may be in fluid communication with thelumen of the graft through a fenestration in a similar manner. Theprosthesis 110 may include a second branch 140 having a proximal region142, a distal region 144, and a lumen 145 extending therebetween. Thesecond branch 140 may extend radially outward from the graft 112, asshown in FIGS. 1-2.

The prosthesis 110 may include one or more fenestrations 150. Thefenestrations 150 may be configured as pivot fenestrations, which may bepivotable in any direction away from an axis perpendicular to alongitudinal axis of the graft 112. Exemplary pivot fenestrations mayinclude those described in U.S. patent application Ser. No. 13/213,349,filed Aug. 19, 2011 or U.S. Provisional Patent Application No.61/375,815, filed Aug. 21, 2010, which are incorporated by referenceherein in their entirety. For example, the prosthesis 110 may include afirst fenestration 160 and a second fenestration 170, which may beconfigured as pivot fenestrations as shown in FIGS. 1-2. The first andsecond fenestrations 160, 170 may have features that are identical toone another. Accordingly, unless otherwise specified, the discussionherein related to the first fenestration 160 may be applicable to thesecond fenestration 170, and vice versa.

FIG. 3 is a close-up view of one example of a pivot fenestration 150.The pivot fenestration 150 may include a fenestration 151 with adiameter. The pivot fenestration 150 may include a first, innerperimeter 152 surrounding the fenestration 151 and having a diameter, aband 154 of flexible material attached to and surrounding the firstperimeter 152, and a second, outer perimeter 156 attached to andsurrounding the band 154. The band 154 may have a first diameter that issubstantially the same as the diameter of the first perimeter 152 and asecond diameter that is substantially the same as the diameter of thesecond perimeter 156. The pivot fenestration 150 may extend from asidewall of the graft 112 such that the diameter of the band 154 maydecrease in a direction away from the surface of the graft 112 from thesecond perimeter 156 to the first perimeter 152. The band 154 mayinclude a flexible frame 158.

In one embodiment, as shown in FIGS. 1-2, the prosthesis 110 may includea first fenestration 160 and a second fenestration 170, each configuredgenerally as described above with reference to the pivot fenestration150. For example, the first fenestration 160 may include a fenestration161, a first, inner perimeter 162, a band 164 of flexible material, anda second, outer perimeter 166. The band 164 may include a flexible frame168. The second fenestration 170 may include a fenestration 171, afirst, inner perimeter 172, a band 174 of flexible material, and asecond, outer perimeter 176. The band 174 may include a flexible frame178.

In one embodiment, the graft 112 may include a tapered portion 124 asshown in FIGS. 1-2. The outer diameter of the tubular body may decreasealong the tapered portion 124 in a proximal to distal longitudinaldirection such that an outer diameter at the proximal end 118 is greaterthan an outer diameter at the distal end 119 of the graft 112. Theproximal regions 132 and 142 of the first and second branches 130, 140,may be disposed proximate, or within, the tapered portion 124. Thefenestrations 160, 170 may be disposed distal to the tapered portion124. The tapered portion 124 may enable the distal regions 134 of thefirst branch 130 and/or the distal region 144 of the second branch 140to extend radially outward relative to the graft 112 withoutsubstantially increasing the overall outer diameter of the prosthesis 10relative to the outer diameter at the proximal end 118 of the graft.

The proximal regions 132, 142 of the first and second branches 130, 140,respectively, may be disposed around a circumference of the graft 112 ata predetermined distance relative to one another. For example, theproximal regions 132, 142 of the first and second branches 130, 140,respectively, may be disposed between about 0 and about 310 degreesapart relative to one another, and more preferably, about 30 degreesapart. Additionally, or alternatively, the proximal regions 132, 142 ofthe first and second branches 130, 140, respectively, may be disposed ata predetermined distance from one another along a longitudinal axis L ofthe graft 112. The proximal region 132 may be proximal to the proximalregion 142 as shown in FIGS. 1-2. Alternatively, the proximal region 132may be distal to the proximal region 142 or the proximal regions 132 and142 may be disposed in close proximity to one another along thelongitudinal axis L.

The first and second branches 130, 140 may extend generallylongitudinally in a distal direction along the graft 112 of theprosthesis 110 as shown in FIGS. 1-2. Alternatively, the first andsecond branches 130, 140 may include desired helical shapes tofacilitate insertion of various components (e.g., side branchprostheses) into the branches as described herein. Additionally, thehelical shapes may reduce torsion imposed by blood flow at the juncturebetween the graft 112 and the branch vessels. Various exemplary helicalbranches that extend from a main body of a prosthesis, which may be usedin conjunction with the present embodiments, are provided in U.S. Pat.No. 7,407,509 to Greenberg et al., which is hereby incorporated byreference in its entirety.

The first and second fenestrations 160, 170, respectively, may bedisposed around a circumference of the graft 112 at a predetermineddistance relative to one another. For example, the first and secondfenestrations 160, 170 may be disposed between about 50 and about 310degrees apart relative to one another, and more preferably, about 150degrees apart. Additionally, or alternatively, the first and secondfenestrations 160, 170, respectively, may be disposed in close proximityto one another along the longitudinal axis L of the graft 112 as shownin FIGS. 1-2. Alternatively, the first and second fenestrations 160 and170 may be disposed at a predetermined distance from one another alongthe longitudinal axis L. For example, the first fenestration 160 may beproximal to the second fenestration 170, or vice versa.

Referring to FIG. 3, the pivot fenestration 150 may include an innerperimeter 152 surrounding the fenestration 151, a band 154 surroundingthe inner perimeter 152, and an outer perimeter 156 surrounding theband. The diameter of the outer perimeter 156 may be greater than thediameter of the band 154 and the diameter of the inner perimeter 152. Inone example, the inner perimeter 152, the band 154, and the outerperimeter 156 would be substantially concentric with one another if theywere in the same plane, for example, the surface plane of the graft 112.The outer perimeter 156 may lie in the same plane as the graft 112. Inother words, the outer perimeter 156 may be substantially flush, even,or aligned with the tubular body of the graft 112. The inner perimeter152, the band 154, and the outer perimeter 156 may form a hemisphericalshape, resembling a dome, or a frustoconical cone extending from thesurface of the graft 112. The fenestration 151 may be provided at thepeak or top of the hemispherical shape or extension. The outer perimeter156 may be affixed to the graft 112 by any attachment method including,for example, suturing circumferentially about an aperture disposedthrough the graft. Although both the inner perimeter 152 and the outerperimeter 156 are shown in FIG. 3 as being substantially circular, theperimeters may be oval, oblong, or any other desired geometric shape.

The pivot fenestration 150 may be located within the lumen 120 of thegraft 112 or may extend externally of the graft. In the first aspect,the pivot fenestration 50 may be said to be concave, relative to theouter surface 122 of the graft 112. In the second aspect, the pivotfenestration 150 may be said to be convex, relative to the outer surface122 of the graft 112. FIG. 3 shows the pivot fenestration 150 locatedinternal to the graft 112. In other words, the pivot fenestration 150lies within the lumen 120 of the graft 112. As such, the pivotfenestration 150 shown in FIG. 3 may be said to be concave, relative tothe outer surface 122 of the graft 112.

The band 154 may be made of the same or a different biocompatiblematerial as the graft 112. For example, the biocompatible material ofthe band 154 may have a greater pliability than the biocompatiblematerial of the graft 112. The band 154 may be sufficiently flexible toenable the fenestration 151 to move relative to the graft 112. In otherwords, the band 154 may be sufficiently flexible to enable the innerperimeter 152 surrounding the fenestration 151 to move relative to thegraft 112. Such movement may enable a prosthesis (e.g., a side branchprosthesis) disposed in the fenestration 151 to be positioned in variousorientations with respect to the longitudinal axis L of the graft 12.For example, a prosthesis may be oriented upwardly, downwardly,laterally, diagonally, and the like with respect to the graft 112. Insome aspects, the band 154 may have up to about 180 degrees of freedomof movement relative to the surface plane of the graft 112. Accordingly,the pivot fenestration 150 may enable the prosthesis 110 to be used witha variety of patients, due to its ability to adapt to the variance inthe positioning of the diseased branch vessels. For example, if a branchvessel is or becomes offset longitudinally or transversely from thepivot fenestration 150, the pivot fenestration may pivot the side branchprosthesis in the necessary direction and to the necessary degree tomaintain the side branch prosthesis in place in the branch vessel. Inone embodiment, the fenestrations 160, 170 of the prosthesis 110 may beconfigured as pivot fenestrations as shown in FIGS. 1-2. Thisconfiguration may allow for variability in the positions of a patient'sleft renal artery 878 and right renal artery 877 when the prosthesis 110is used to treat a thoracoabdominal aneurysm as described below.

In one embodiment, the pivot fenestration 150 may include areinforcement frame as shown in FIGS. 3 and 5. The reinforcement framemay be sutured or otherwise attached to the graft 112. For example, areinforcement frame 181 may be positioned about the outer perimeter 156.Additionally, or alternatively, a reinforcement frame 182 may bepositioned about the inner perimeter 152. The reinforcement frames 181,182 may be rings. In one preferred aspect, the reinforcement frames 181,182 may be wires that are sutured about the respective perimeters toreinforce the pivot fenestration 150. The reinforcement frames 181, 182may be made of any suitable material. One preferred material is asuperelastic or shape memory material such as nitinol. In anotherpreferred embodiment, the reinforcement frames 181, 182 may be made ofradiopaque or other imageable material. In another embodiment, thereinforcement frames 181, 182 may be solid rings. Alternatively, thereinforcement frames 181, 182 may be wires looped about themselves intorings with unattached ends such that the rings may be expanded orcontracted in diameter. Suitable frames are disclosed in U.S. PatentApplication Publication No. 2005/0102021 by Osborne, which is herebyincorporated by reference in its entirety.

FIG. 4 shows a partial, cross-sectional view of a portion of theprosthesis 110, having a pivot fenestration 150. The band 154 may betapered such that the diameter decreases throughout its depth γ. Thedepth γ may be determined based on the amount of movement desired forthe pivot fenestration 150 during use and the ability to cannulate thetargeted branch vessel. As the depth γ decreases, the amount of secondbiocompatible material used for the band 154 also may decrease, whichmay limit the range of motion of the pivot fenestration 150.Furthermore, the depth γ may be large enough to enable cannulation ofthe targeted branch vessel. The depth γ may range from about 3 to about10 mm, and preferably is about 6 mm. The inner perimeter 152 may have adiameter α that is smaller than the diameter β of the outer perimeter156. The diameter α of the inner perimeter 152 may be determined basedon the average size of the targeted branch vessel. In one aspect, theprosthesis 110 may be used to repair a diseased renal artery.Accordingly, the diameter α of the inner perimeter 152 may be based onthe average diameter of the openings to the renal arteries, or about 6mm.

The diameter β of the outer perimeter 156 may be determined based on thedesired amount of movement and the desired patency of the prosthesis110. As the diameter β of the outer perimeter 156 changes, the range ofmotion provided by the pivot fenestration 150 also changes. For example,as the diameter β of the outer perimeter 156 decreases, the range ofmotion also decreases. Additionally, the diameter β of the outerperimeter 156 may be sized to prevent interference withcircumferentially adjacent struts of a stent 114, that may be alignedwith the pivot fenestration 150 along the longitudinal axis L of thegraft 112. Hence, in one example, the diameter β of the outer perimeter156 may be at most about 15 mm to accommodate the stent 114. Thediameters α and β combined with the depth γ may provide the band 154with sufficient surface area for the pivot fenestration 150 to pivotduring deployment of a secondary prosthesis into the fenestration 151after deployment of the prosthesis 110 within the patient's body. Thepivot fenestration 150 also may pivot after deployment of the secondaryprosthesis therein based on dynamic changes to the patient's anatomy(i.e., movement).

FIGS. 5-6 show an internal view and an external view, respectively, of apivot fenestration 150 in an aspect in which the pivot fenestration isdisposed within the lumen 120 of the graft 112. FIG. 5 shows thefenestration 151, the inner perimeter 152, the band 154, and the outerperimeter 156. The reinforcement frame 181 may be positioned about theouter perimeter 156, and the reinforcement frame 182 may be positionedabout the inner perimeter 152. The reinforcement frames 181, 182 may beaffixed to the outer perimeter 156 and the inner perimeter 152,respectively as described above. Markers 105 may be placed around theinner perimeter 152 to facilitate proper placement and alignment of aside branch prosthesis and the fenestration 151.

As shown in FIG. 5, the band 154 may be provided with a flexible frame183. The flexible frame 183 may provide structural support to the band154 to prevent the pivot fenestration 150 from everting or inverting(depending on the initial configuration) once the prosthesis 110 isdeployed with the diseased vessel. The flexible frame 183 may bepositioned on the band 154 either on the interior or exterior surface ofthe band. In one example, the flexible frame 183 may be positioned onthe interior surface of the band 154 as shown in FIGS. 5-6. The flexibleframe 183 may include a continuous wire formed into a plurality ofsupport units 184. Each support unit 184 may have a generally undulatingshape including straight struts 185 interconnected by outwardly facingapices or bends 186. The number of support units 184 may range fromabout 2 support units to about 10 support units. In a preferredembodiment, the flexible frame 183 has three support units 184.

In one example, the outwardly facing apices 186 of the flexible frame183 may abut or connect to the reinforcing frame 181 of the outerperimeter 156 of the pivot fenestration 150 as shown in FIGS. 5-6. Theoutwardly facing apices 186 may be, for example, sewn or sutured to thereinforcing frame 181. The flexible frame 183 may be bent to form aplurality of loops 187. The loops 187 may be positioned in the troughsformed between adjacent support units 184. Each loop 187 may abut and/orconnect to the reinforcing frame 182 of the inner perimeter 152 of thepivot fenestration 150. The loops 187 may be, for example, sewn orsutured to the reinforcing frame 182. A loop 188 may be positionedwithin an apex 186 of a support unit 184. Other configurations for theflexible frame 183 including, but not limited to, spirals also may besuitable. The flexible frame 183 may be heat set into the desiredconfiguration prior to attachment to the band 154. The flexible frame183 may be made of an elastic or superelastic material such as, forexample and without limitation, nitinol.

The band 154 of the pivot fenestration 150 may be formed from aprotrusion 190 having a bubble like configuration as shown in FIG. 7.The protrusion may be formed using processes such as those described inU.S. Patent Application Publication No. 2010/0063576 by Schaeffer et al.which is hereby incorporated by reference in its entirety. Theprotrusion 190 may be integrally formed with the body of the graft 112and may include a second biocompatible graft material. The protrusion190 may be created during the weaving process used to create the graftmaterial of the graft 112. The graft material may be woven in weavesincluding, but not limited to, plain weaves, basket weaves, rep or ribweaves, twill weaves (e.g., straight twill, reverse twill, herringbonetwill), satin weaves, and double weaves (e.g., double-width, tubulardouble weave, reversed double weave). Desirably, the weave may include atubular double layer weave. The fabric may be woven on a table loom, afloor loom, a jacquard loom, a counterbalance loom, a jack loom, or anupright loom. Desirably, the fabric may be woven on a floor loom. Thefabric may have any configuration possible, but preferably has warp andweft yarns. In one aspect, both the warp yarns and the weft yarns aretextile yarns.

To create the protrusion 190, the number of warp yarns used whileweaving the graft material of the graft 112 may be increased in theregion where the protrusion 190 is desired. While the additional warpyarns are woven into the graft 112, the number of weft yarns may be keptconstant. By increasing the number of warp yarns while holding thenumber of weft yarns constant, the second biocompatible graft materialexpands outwardly in the radial direction. The number of warp yarns maybe increased until a pre-determined diameter has been reached. Once thedesired depth for the protrusion 190 is reached, the number of warpyarns introduced into the weaving apparatus may be decreased until thenumber of warp yarns is equal to the number of weft yarns used to formthe remainder of the graft 112. A fenestration may be created throughthe protrusion 190 by any suitable means. For example, the fenestrationmay be created by applying heat to the center of the protrusion 190.Reinforcing frames may be added about the fenestration and adjacent toand surrounding the protrusion 190 to form the inner and outerperimeters 152 and 156, respectively, of the pivot fenestration 150.Further, a flexible frame 183 may be attached to the protrusion 190 tomaintain the protrusion in a desired extended configuration.

The prosthesis 110 may have a compressed, reduced diameter deliverystate in which the prosthesis may be advanced to a target locationwithin a vessel, duct, or other anatomical site, such as thethoracoabdominal aorta as described below with reference to FIGS.14A-15G. The prosthesis 110 may have an expanded state, as shown inFIGS. 1-2, in which the prosthesis may be configured to apply a radiallyoutward force upon the vessel, duct, or other target location. In theexpanded state, fluid flow may be allowed through the lumen 120 of thegraft 112.

The prosthesis 110 may include one or more radiopaque markers 105 toprovide radiographic visualization of the position of the endoluminalprosthesis 110 when placed in the vessel or duct of a patient. Aplurality of radiopaque markers 105, which according to one example maybe provided in the form of gold beads, may be coupled to the graft 112,the stents 114, the branches 130, 140, and/or the fenestrations 160, 170to facilitate imaging of various desired locations along the length ofthe endoluminal prosthesis 110. The radiopaque markers 105 may bepositioned at the proximal end 118 and/or the distal end 119 of thegraft 112. The radiopaque markers also may be positioned proximate thefirst branch 130 and/or the second branch 140 and/or proximate to thefirst fenestration 160 and/or the second fenestration 170 to facilitateimaging of those portions of the prosthesis 110.

FIGS. 8-9 depict another embodiment of a prosthesis 210, which may beconfigured as a stent graft. The prosthesis 210 may include a graft 212including a generally tubular body of a biocompatible material. Thegraft 212 may have a proximal end 218, a distal end 219, and a lumen 220extending therebetween. The graft 212 may include a fenestration 250disposed in the graft 212 at a location between the proximal end 218 andthe distal end 219. The fenestration 250 may be configured as aself-sealing fenestration as further described below.

The graft 212 may include four openings each configured as a branch asshown in FIGS. 8-9. For example, the graft 212 may include a firstbranch 230 having a proximal region 232, a distal region 234, and alumen 235 extending therebetween. The first branch 230 may extendradially outward from the graft 212 as shown in FIGS. 8-9. The proximalregion 232 of the first branch 230 may be disposed at a locationproximal to the fenestration 250 as best shown in FIG. 9.

The graft 212 may include a second branch 240 having a proximal region242, a distal region 244, and a lumen 245 extending therebetween. Thesecond branch 240 may extend radially outward from the graft 212 asshown in FIGS. 8-9. The proximal region 242 of the second branch 240 maybe disposed at a location proximal to the fenestration 250 as best shownin FIG. 9.

The graft 212 may include a third branch 260 having a proximal region262, a distal region 264, and a lumen 265 extending therebetween. Thethird branch 260 may extend radially outward from the graft 212 as shownin FIGS. 8-9. The proximal region 262 of the third branch 260 may bedisposed at a location distal to the fenestration 250 as best shown inFIG. 9.

The graft 212 may include a fourth branch 270 having a proximal region272, a distal region 274, and a lumen 275 extending therebetween. Thefourth branch 270 may extend radially outward from the graft 212 asshown in FIGS. 8-9. The proximal region 272 of the fourth branch 270 maybe disposed at a location distal to the fenestration 250 as shown inFIGS. 8-9.

In one embodiment, the distal region 234 of the first branch 230, thedistal region 244 of the second branch 240, and the distal region 264 ofthe third branch 260 each may extend in a distal direction with respectto the graft 212 toward the distal end 219 of the graft 212 as shown inFIG. 8. The distal region 274 of the fourth branch 270 may extend in aproximal direction with respect to the graft 212 toward the proximal end218 of the graft 212. Such orientations of the distal regions of thefour branches 230, 240, 260, and 270 may facilitate insertion of fourcorresponding side branch prostheses. For example, in the exemplarymethod of FIGS. 18A-18L shown and described below, side branchprostheses 830, 840 and 820 may be delivered in a proximal to distaldirection with respect to the graft 212 for the branches 230, 240, and260, respectively, while another side branch prosthesis 850 may bedelivered in a distal to proximal direction with respect to the graft212 for the branch 270.

In one embodiment, the graft 212 may have a tapered portion 224 as shownin FIGS. 8-9. The tapered portion 224 may be configured generally asdescribed above with reference to the tapered portion 124 of theprosthesis 110. The proximal regions 232, 242 of the first and secondbranches 230, 240, respectively, may be disposed proximal to, or within,the tapered portion 224. The fenestration 250 and the proximal regions262, 272 of the third and fourth branches 260, 270, respectively, may bedisposed distal to the tapered portion 224. Alternatively, thefenestration 250 may be disposed within the tapered portion 224, or atany suitable location distal to the distal region 234 of the firstbranch 230 for purposes described below. The tapered portion 234 mayenable the distal regions of one or more of the branches 230, 240, 260,and/or 270 to extend radially outward relative to the graft 212 withoutsubstantially increasing the overall outer diameter of the prosthesis210 relative to an outer diameter at the proximal end 218 of the graft212.

The proximal regions 232, 242 of the first and second branches 230, 240,respectively, may be disposed around a circumference of the graft 212 ata predetermined distance relative to one another. For example, theproximal regions 232, 242 of the first and second branches 230, 240,respectively, may be disposed between about 50 and about 310 degreesapart relative to one another, and more preferably, about 180 degreesapart. Additionally, or alternatively, the proximal regions 232, 242 ofthe first and second branches 230, 240, respectively, may be disposed inclose proximity to one another along a longitudinal axis L of the graft212, as shown in FIG. 8. Alternatively, the proximal region 232 of thefirst branch 230 may be disposed proximal to the proximal region 242 ofthe second branch 240, or vice versa.

The proximal regions 262, 272 of the third and fourth branches 260, 270,respectively, may be disposed around a circumference of the graft 212 ata predetermined distance relative to one another. For example, theproximal regions 262, 272 of the third and fourth branches 260, 270,respectively, may be disposed between about 50 and about 310 degreesapart relative to one another, and more preferably, about 180 degreesapart. Additionally, or alternatively, the proximal region 262 of thethird branch 260 may be disposed proximal to the proximal region 272 ofthe fourth branch 270, as shown in FIG. 8, or vice versa. Alternatively,the proximal regions 262, 272 of the third and fourth branches 260, 270,respectively, may be disposed in close proximity to one another along alongitudinal axis L of the graft 212.

Any of the four branches 230, 240, 260, and 270 may include desiredhelical shapes to facilitate insertion of various components describedherein. Additionally, the helical shapes may reduce torsion imposed byblood flow at the juncture between the graft 212 and the branch vessels.The helical shapes depicted herein are for illustrative purposes onlyand are not intended to be limiting. Various exemplary helical branchesthat extend from a main graft, which may be used in conjunction with thepresent embodiments, are provided in U.S. Pat. No. 7,407,509 toGreenberg et al., which is hereby incorporated by reference in itsentirety.

The prosthesis 210 may include at least one stent coupled to the graft212. For example, a plurality of stents 214 a may be coupled to an innersurface of the graft 212 along a proximal region of the graft 212, whilea plurality of stents 214 b may be coupled to an outer surface of thegraft 212 along a distal region of the graft 212 as shown in FIGS. 8-9.While one exemplary arrangement is shown in FIGS. 8-9, it will beappreciated that any of the stents 214 may be coupled to inner and/orouter surfaces of the graft 212. The stents 214 may be configuredgenerally as described above with reference to the stents 114 of theprosthesis 110.

The graft 212 may have a compressed, reduced diameter delivery state inwhich the graft may be advanced to a target location within a vessel,duct or other anatomical site, such as the thoracoabdominal aorta asshown below in FIGS. 14A-14F and 18A-18L. The graft 212 may have anexpanded state, as shown in FIGS. 8-9, in which the graft may beconfigured to apply a radially outward force upon the vessel, duct orother target location. In the expanded state, fluid flow may be allowedthrough the lumen 220 of the graft 212.

The prosthesis 210 may include one or more radiopaque markers 205 toprovide radiographic visualization of the position of the endoluminalprosthesis 210 when placed in the vessel or duct of a patient. Aplurality of radiopaque markers 205, which according to one example maybe provided in the form of gold beads, may be coupled to the graft 212and/or the stents 214 to facilitate imaging of various desired locationsalong the length of the prosthesis 210.

In any of the embodiments described herein, at least one fenestrationmay be configured as a self-sealing fenestration. For example, thefenestration 250 of the prosthesis 210 may be configured as aself-sealing fenestration to allow various delivery components (e.g., aguide wire, a catheter, a sheath, or an introducer) to be passed throughthe graft 212 as further described below without leakage through thegraft upon removal of the wire. In other examples, any of thefenestrations described herein may be configured as self-sealingfenestrations. The self-sealing fenestration may include a resilientflap of material that may cover the fenestration via a spring force uponremoval of the wire. One suitable exemplary self-sealing fenestration isdescribed and shown in U.S. Patent Application Publication No.2007/0250154 by Greenberg et al., which is hereby incorporated byreference in its entirety.

An endoluminal prosthesis (e.g., the prosthesis 110, shown in FIGS. 1-2,or the prosthesis 210, shown in FIGS. 8-9) may be delivered into apatient's thoracoabdominal aorta using a suitable delivery device orintroducer. FIG. 10A shows one example of a delivery device 500 in acondition for introduction of an endoluminal prosthesis into a patient,and FIG. 10B shows the delivery device of FIG. 10A with the sheathwithdrawn to show the prosthesis. It is unlikely that the particularconfiguration shown in FIG. 10B would actually occur in use because, bythe time that the sheath has been withdrawn to expose the prosthesis,the length extending module should have been withdrawn as is discussedbelow. Although FIG. 10B shows the delivery device 500 with theprosthesis 110 loaded thereon, the delivery device 500 may be used todeliver the prosthesis 210 in a similar manner. In other examples, thedelivery device 500 may be used to deliver a prosthesis having any othersuitable configuration.

The delivery device 500 may include a handle portion 510 and anintroduction portion 520. The handle portion 510 is intended to remainoutside of the patient in use, and the introduction portion 520 isintended to be introduced into the patient via a puncture in an arterysuch as the femoral artery. A catheter, such as the pusher catheter 530,may extend proximally from a trigger wire release region 512 of thehandle 510. A pusher catheter hub 532 may be positioned near the distalend of the pusher catheter 530 and configured to receive one or moreauxiliary sheaths 540 and/or auxiliary guide wires 542 as furtherdescribed below. A sheath 550 and a sheath hub 552 may extend over atleast a portion of the pusher catheter 530. The sheath 550 may extendproximally to a nose cone dilator 560. The sheath 550 may be retractedrelative to the pusher catheter 530 to expose a prosthesis retainedbelow the sheath as further described below. A guide wire cannula 580may extend from a connector 582 (e.g., a Luer lock hub) positioned atthe distal end of the delivery device 500, through the handle 510 andthe pusher catheter 530 to extend to the nose cone dilator 560. Theguide wire cannula 580 may be received within a main lumen of the pushercatheter 530. The guide wire cannula 580 may extend at least partiallythrough the nose cone dilator 560. The guide wire cannula 580 may betracked over a guide wire in a conventional manner to guide the deliverydevice through the vasculature of the patient. The connector 582 may beused to introduce liquids such as contrast media to enable tracking ofthe progress of an operation.

The nose cone dilator 560 may be positioned at the proximal end of theguide wire cannula 580 and may include one or more longitudinal grooves562 on an outside longitudinal surface of the nose cone dilator. Thegrooves 562 are shown in greater detail in FIGS. 11A-11D. One or moreauxiliary guide wires 542 may be received within the grooves 562 asfurther described below. The length of the nose cone dilator may bereduced relative to conventional delivery devices. Such a reduced lengthmay reduce the length of the auxiliary guide wire 542 that is exposed onthe outside longitudinal surface of the nose cone dilator 560 duringdelivery of a prosthesis. A length extending module (LEM) 590 may bereleasably mounted to the proximal end of the nose cone dilator 560. TheLEM 590 may be configured to carry an auxiliary guide wire beyond thesite of placement of a prosthesis to establish through-and-throughaccess during deployment of the prosthesis as further described below.The LEM 590 may include an outer sheath 592 surrounding a dilator 594 asshown in FIGS. 10A-10B and 11. In one example, the outer sheath 592 mayhave a size of about 8 Fr. The dilator 594 of the LEM 590 may includeone or more longitudinal grooves 596. The longitudinal grooves 596 mayextend generally longitudinally along the dilator 594 as furtherdescribed below. One or more auxiliary guide wires 542 may be receivedwithin the longitudinal grooves 596 also as further described below. TheLEM 590 also may include a guide wire lumen 598, which may be in fluidcommunication with the guide wire cannula 580 to enable the deliverydevice 500 to be tracked over a guide wire in a conventional manner. Thereleasable mounting between the LEM 590 and the nose cone dilator 560may be achieved by any of the examples described below in reference toFIGS. 12A-13B. In other examples, the releasable mounting may beachieved by any other suitable means without departing from the scope ofthis disclosure. For example, the LEM 590 may be releasably attached tothe nose cone dilator 560 as described in World Intellectual PropertyOrganization Publication No. 2011/116308, which is incorporated byreference herein in its entirety.

The pusher catheter hub 532 may include one or more side ports 534. Inone example, the pusher catheter hub 532 may be configured as a tri-porthub. To that end, the pusher catheter hub 532 may include a centralport, a first side port 534 a, and a second side port 534 b as shown inFIGS. 10A-10B. The guide wire cannula 580 may be received within thecentral port of the pusher catheter hub 532. Each side port 534 mayextend outward from the pusher catheter hub 532. Each side port 534 alsomay extend distally relative to the pusher catheter hub 532 as shown inFIGS. 10A-10B. An auxiliary guide wire 542 and/or an auxiliary sheath540 may be received within each side port 534 as further describedbelow. The side ports 534 may be positioned circumferentially apartaround the pusher catheter hub 532. In one example, the first side port534 a may be positioned on a top side of the pusher catheter hub 532,and the second side port 534 b may be positioned on a bottom side of thepusher catheter hub generally opposite the first side port with respectto the circumference of the pusher catheter hub. This configuration isillustrative, and the side ports 534 may be positioned at anycircumferential positions on the pusher catheter hub 532.

Each side port 534 of the pusher catheter hub 532 may be in fluidcommunication with an auxiliary lumen of the pusher catheter 530. Tothat end, the pusher catheter 530 may have one or more auxiliary lumens536 extending generally longitudinally within the pusher catheter. FIG.10C shows a transverse cross-sectional view of the delivery device 500taken along line 10C-10C′ of FIG. 10A. In this example, the pushercatheter 530 may include a first auxiliary lumen 536 a and a secondauxiliary lumen 536 b. The auxiliary lumens 536 may be positioned in theannular region of the pusher catheter 530 between the guide wire cannula580 and the exterior surface of the pusher catheter. In one example, thefirst auxiliary lumen 536 a and the second auxiliary lumen 536 b may bepositioned adjacent one another and near the top of the pusher catheter530 as shown in FIG. 10C. In other examples, the auxiliary lumens 536may be positioned generally opposite one another with respect to thecircumference of the pusher catheter 530, or in any other orientationrelative to one another. In one example, the auxiliary lumens 536 mayhave a size of about 6 Fr.

Each auxiliary lumen 536 may extend from the pusher catheter hub 532 tothe proximal end of the pusher catheter 530. FIG. 10D shows the proximalend of the pusher catheter 530. The proximal end of the pusher catheter530 may include a tapered transition 538. The diameter of the taperedtransition 538 may taper from the diameter of the pusher catheter 530 tothe diameter of the guide wire cannula 580. Each auxiliary lumen 536 mayextend through the tapered transition 538 to provide a continuouspathway between the corresponding side port 534 and the proximal end ofthe pusher catheter 530. In other examples, the proximal end of thepusher catheter 530 may be blunt as opposed to tapered. In theseexamples, each auxiliary lumen 536 may extend through the blunt proximalend to provide a continuous pathway between the corresponding side port534 and the proximal end of the pusher catheter 530.

An auxiliary sheath 540 may be received within each of the side ports534 and each of the auxiliary lumens 536 as shown in FIGS. 10A-10D. Forexample, a first auxiliary sheath 540 a may extend through the firstside port 534 a and into the first auxiliary lumen 536 a. The firstauxiliary sheath 540 a may extend proximally within the first auxiliarylumen 536 a and exit the proximal end of the pusher catheter 530. Asecond auxiliary sheath 540 b may extend through the second side port534 b and into the second auxiliary lumen 536 b. The second auxiliarysheath 540 b may extend proximally within the second auxiliary lumen 536b and exit the proximal end of the pusher catheter 530. The auxiliarysheaths 540 may further extend proximally into the prosthesis loaded onthe delivery device as described below.

One or more auxiliary guide wires 542 may be received within the sideports 534 and the auxiliary lumens 536. The one or more auxiliary guidewires 542 also may be received within the auxiliary sheaths 540. Forexample, an auxiliary guide wire 542 may extend within the firstauxiliary sheath 540 a and through the first side port 534 a. Theauxiliary guide wire 542 may extend proximally within the firstauxiliary lumen 536 a and exit the proximal end of the pusher catheter530. The auxiliary guide wire 542 may extend further proximally into theprosthesis and along the LEM 590 as described below. The auxiliary guidewire 542 may extend distally from the LEM 590 and into the secondauxiliary sheath 540 b. The auxiliary guide wire 542 may extend withinthe second auxiliary sheath 542 b and into the second auxiliary lumen536 b. The auxiliary guide wire 542 may extend distally within thesecond auxiliary lumen 536 b and through the side port 534 b to exit thepusher catheter 530.

FIG. 10B depicts the prosthesis 110 releasably retained on the deliverydevice 500. The prosthesis 110, or another prosthesis, may be positionedon the delivery device 500 distal of the nose cone dilator 560. Theprosthesis 110 may be retained in a compressed condition within thesheath 550. Upon retraction of the sheath 550, the prosthesis 110 mayexpand to a partially expanded configuration as shown in FIG. 10B. Inthe partially expanded configuration, the proximal end 118 of theprosthesis 110 may be retained by one or more releasable trigger wires(not shown) to form one or more lobes of graft material 118 a at theproximal end of the prosthesis. Access through the open lobes of graftmaterial 118 a may be achieved to track an access catheter over one ormore auxiliary guide wires as described below.

In one example, one or more auxiliary sheaths 540 may be received withinthe prosthesis 110. The auxiliary sheaths may be preloaded in theprosthesis 110 prior to delivery of the prosthesis within thevasculature of the patient. For example, the first auxiliary sheath 540a may exit the proximal end of the pusher catheter 530 as describedabove and enter the distal end 119 of the prosthesis 110 as shown inFIGS. 1-2 and 10B. The first auxiliary sheath 540 a may extendproximally within the lumen 120 of the prosthesis 110 and through thefirst fenestration 160. The proximal end of the first auxiliary sheath540 a may be positioned external of the prosthesis 110 near the firstfenestration 160. In other words, the proximal end of the firstauxiliary sheath 540 a may be positioned generally adjacent the outersurface 122 of the graft 112 of the prosthesis 110 near the firstfenestration 160. In one example, the first auxiliary sheath 540 a mayextend about 5 cm beyond the first fenestration 160 of the prosthesis110.

Similarly, the second auxiliary sheath 540 b may exit the proximal endof the pusher catheter 530 as described above and enter the distal end119 of the prosthesis 110. The second auxiliary sheath 540 b may extendproximally within the lumen 120 of the prosthesis 110 and through thesecond fenestration 170. The proximal end of the second auxiliary sheath540 b may be positioned external of the prosthesis 110 near the secondfenestration 170. In other words, the proximal end of the secondauxiliary sheath 540 b may be positioned generally adjacent the outersurface 122 of the graft 112 of the prosthesis 110 near the secondfenestration 170. In one example, the second auxiliary sheath 540 b mayextend about 5 cm beyond the second fenestration 170 of the prosthesis110. The first and second auxiliary sheaths 540 a, 540 b may aid incannulating the respective first and second fenestrations 160, 170 withbranch prostheses upon deployment of the prosthesis 110 as furtherdescribed below. Preloading the auxiliary sheaths within the prosthesis110 prior to deployment of the prosthesis may reduce the amount of timerequired to deploy the prosthesis by obviating the need to cannulateeach of the fenestrations with a sheath after the prosthesis has beenintroduced within the body of the patient. Preloading the auxiliarysheaths also may reduce the amount of catheter manipulation requiredduring a deployment procedure.

In one example, the auxiliary guide wire 542 may be received within theprosthesis 110, or another prosthesis, and the delivery device 500 in apreloaded configuration as further described below. The auxiliary guidewire 542 may be preloaded in the prosthesis 110 prior to delivery of theprosthesis within the vasculature of the patient. A first portion 542 aof the auxiliary guide wire 542 (i.e., a first wire segment), which maybe received within the first auxiliary sheath 540 a preloaded in theprosthesis 110, may pass through an end opening at the distal end 119 ofthe prosthesis and extend proximally within the lumen 120 of theprosthesis as shown in FIGS. 1-2 and 10B. The first portion 542 a of theauxiliary guide wire 542 may pass through the first fenestration 160 toexit the prosthesis 110 and extend proximally external to theprosthesis. The first portion 542 a of the auxiliary guide wire 542 mayexit the proximal end of the first auxiliary sheath 540 a and extendfurther proximally external to the prosthesis 110. The first portion 542a of the auxiliary guide wire 542 may pass through an end opening at thedistal region 134 of the first branch 130 and extend proximally withinthe lumen 135 of the first branch. The first portion 542 a of theauxiliary guide wire 542 may pass through an end opening at the proximalregion 132 of the first branch 130 and extend proximally within thelumen 120 of the prosthesis 110 to exit an end opening at the proximalend 118 of the prosthesis. The first portion 542 a of the auxiliaryguide wire 542 may extend further proximally to engage the LEM 590 asfurther described below.

A second portion 542 b of the auxiliary guide wire 542 (i.e., a secondwire segment) may pass through the end opening at the proximal end 118of the prosthesis 110 and extend distally within the lumen 120 of theprosthesis 110. The second portion 542 b of the auxiliary guide wire 542may pass through an end opening at the proximal region 142 of the secondbranch 140 and extend distally within the lumen 145 of the secondbranch. The second portion 542 b of the auxiliary guide wire 542 maypass through an end opening at the distal region 144 of the secondbranch 140 to exit the prosthesis 110 and extend distally external tothe prosthesis. The second portion 542 a of the auxiliary guide wire 542may enter the proximal end of the second auxiliary sheath 540 b andextend distally external to the prosthesis within the second auxiliarysheath. The second portion 542 b of the auxiliary guide wire 542 maypass through the second fenestration 170 and extend distally within thelumen 120 of the prosthesis 110 to exit the end opening at the distalend 119 of the prosthesis. In this manner, the single auxiliary guidewire 542 may pass through each of the first and second branches 130, 140and the first and second fenestrations 160, 170. The auxiliary guidewire 542 may not penetrate the graft 112 (i.e., the sidewall of the maintubular graft body) at any location other than the branches and/or thefenestrations. This may reduce the potential for leakage through thegraft 112 after removal of the auxiliary guide wire 542 as describedbelow. The auxiliary guide wire 542 may aid in cannulating each of thefirst and second branches 130, 140 and the first and secondfenestrations 160, 170 with branch prostheses upon deployment of theprosthesis 110 as further described below. In other examples, theauxiliary guide wire 542 may include two or more auxiliary guide wires.For example, the first portion 542 a and the second portion 542 b of theauxiliary guide wire may be configured as separate auxiliary guidewires. In other words, the first portion 542 a of the auxiliary guidewire 542 may be configured as a first wire segment, and the secondportion 542 b of the auxiliary guide wire may be configured as a secondwire segment. The first and second wire segments may be joined to oneanother or separate from one another (i.e., unattached).

In another example, the auxiliary guide wire 542 may be received withinthe prosthesis 210 and the delivery device 500 in a preloadedconfiguration as further described below. The auxiliary guide wire 542may be preloaded in the prosthesis 210 prior to delivery of theprosthesis within the vasculature of the patient as shown in FIGS. 8-9.The first portion 542 a of the auxiliary guide wire 542 (i.e., the firstwire segment) may extend along an outer surface of the distal end 219 ofthe graft 212. The first portion 542 a of the auxiliary guide wire 542may pass through an end opening at the distal region 264 of the thirdbranch 260 and extend proximally within the lumen 265 of the thirdbranch. The first portion 542 a of the auxiliary guide wire 542 may passthrough an end opening at the proximal region 262 of the third branch260 and extend proximally within the lumen 220 of the prosthesis 210 arelatively short distance. The first portion 542 a of the auxiliaryguide wire 542 may pass through the fenestration 250 to exit theprosthesis 210 and extend proximally external to the prosthesis. Thefirst portion 542 a of the auxiliary guide wire 542 may pass through anend opening at the distal region 234 of the first branch 230 and extendproximally within the lumen 235 of the first branch. The first portion542 a of the auxiliary guide wire 542 may pass through an end opening atthe proximal region 232 of the first branch 230 and extend proximallywithin the lumen 220 of the prosthesis 210 to exit an end opening at theproximal end 218 of the prosthesis. The first portion 542 a of theauxiliary guide wire 542 may extend further proximally to engage the LEM590 as further described below.

The second portion 542 b of the auxiliary guide wire 542 (i.e., thesecond wire segment) may pass through the end opening at the proximalend 218 of the prosthesis 210 and extend distally within the lumen 220of the prosthesis 210. The second portion 542 b of the auxiliary guidewire 542 may pass through an end opening at the proximal region 242 ofthe second branch 240 and extend distally within the lumen 245 of thesecond branch. The second portion 542 b of the auxiliary guide wire 542may pass through an end opening at the distal region 244 of the secondbranch 240 to exit the prosthesis 210 and extend distally external tothe prosthesis. The second portion 542 a of the auxiliary guide wire 542may pass through an end opening at the distal region 274 of the fourthbranch 270 and extend proximally within the lumen 275 of the fourthbranch (i.e., distally relative to the graft 212). The second portion542 b of the auxiliary guide wire 542 may pass through an end opening atthe proximal region 272 of the fourth branch 279 and extend distallywithin the lumen 220 of the prosthesis 210 to exit the end opening atthe distal end 119 of the prosthesis. In this manner, the singleauxiliary guide wire 542 may pass through each of the first, second,third, and fourth branches 230, 240, 260, 270. The auxiliary guide wire542 may not penetrate the graft 212 (i.e., the sidewall of the maintubular graft body) at any location other than the branches and/or thefenestrations. This may reduce the potential for leakage through thegraft 212 after removal of the auxiliary guide wire 542 as describedbelow. The auxiliary guide wire 542 may aid in cannulating each of thefirst, second, third, and fourth branches 230, 240, 260, 270 with branchprostheses upon deployment of the prosthesis 210 as further describedbelow. In other examples, the auxiliary guide wire 542 may include twoor more auxiliary guide wires as described above.

FIG. 11 shows a proximal portion of the delivery device 500. FIG. 11A isa cross-sectional view of the nose cone dilator 560 taken along line11A-11A′ of FIG. 11. The nose cone dilator 560 may be surrounded by thesheath 550. One or more longitudinal grooves 562 may extend generallylongitudinally along an outer surface of the nose cone dilator 560. Inone example, two longitudinal grooves 562 may be diametrically oppositeone another with respect to the outer surface of the nose cone dilator560 as shown in FIG. 11A. In other examples, any number of longitudinalgrooves may be positioned in any arrangement on the nose cone dilator560. The auxiliary guide wire 542 may be received within thelongitudinal grooves 562 as further described below. FIG. 11B is across-sectional view of the tapered tip 566 of the nose cone dilator 560taken along line 11B-11B′ of FIG. 11. The longitudinal grooves 562 mayextend generally longitudinally along the outer surface of the taperedtip 566 of the nose cone dilator 560 as described above in reference tothe longitudinal grooves extending along the nose cone dilatorgenerally. The longitudinal grooves 562 may be configured as generallyU-shaped grooves formed in the surface of the nose cone dilator 560 asshown in FIG. 11C. Alternatively, the longitudinal grooves 562 may beconfigured as a substantially closed tube except for a narrow, elongatedopening 563 as shown in FIG. 11D.

In one example, the tapered tip 566 of the nose cone dilator 560 mayinclude substantially closed longitudinal grooves 562 as shown in FIG.11D. With the auxiliary guide wire 542 retained in the substantiallyclosed groove, as further described below, the probability of theauxiliary guide wire coming out of the groove unintentionally duringdeployment of the prosthesis may be reduced. This may reduce theprobability of the auxiliary guide wire 542 becoming entangled withother portions of the delivery device 500. The nose cone dilator 560 maybe formed from a polyurethane material which exhibits a degree ofelasticity or flexibility so that the nose cone dilator may be deflectedto enlarge the opening 563 of the longitudinal groove 562 to enableremoval of the auxiliary guide wire 542 from the longitudinal groove.During delivery of the prosthesis, as further described below, a sheathand/or a dilator may be advanced over the auxiliary guide wire 543 fromthe proximal end and/or the distal end of the delivery device 500. Thedilator may draw the auxiliary guide wire 542 out of the substantiallyclosed longitudinal groove 562.

FIG. 11E is a cross-sectional view of the LEM 590 taken along line11E-11E′ of FIG. 11. The dilator 594 of the LEM 590 may be surrounded bythe sheath 592 of the LEM. One or more longitudinal grooves 596 mayextend generally longitudinally along an outer surface of the dilator594 of the LEM 590. The longitudinal grooves 596 of the LEM 590 maygenerally align with the longitudinal grooves 562 of the nose conedilator 560. To that end, in one example, two longitudinal grooves 596may be diametrically opposite one another with respect to the outersurface of the LEM 590 as shown in FIG. 11E. In other examples, anynumber of longitudinal grooves may be positioned in any arrangement onthe LEM 590. The longitudinal grooves 596 of the LEM 590 may beconfigured substantially as described above with reference to thelongitudinal grooves 562 of the nose cone dilator 560.

FIG. 11F shows a transverse cross-sectional view taken along line11F-11F′ of FIG. 11. Near the proximal end 595 of the dilator 594 of theLEM 590, a cross aperture 599 may extend through the dilator between twolongitudinal grooves 596. The cross aperture 599 may provide a pathwayconnecting the two longitudinal grooves 596 through the dilator 594. Inother words, the cross aperture 599 may extend through the dilator in atransverse direction with respect to the longitudinal axis of thedilator to connect the two longitudinal grooves 596. This may enable theauxiliary guide wire 542 to cross over from one longitudinal groove 596to another longitudinal groove at the cross aperture 599. By crossingover from one longitudinal groove 596 to another longitudinal groove,the auxiliary guide wire 542 may be capable of extending proximallyalong the length of the LEM 590 within one longitudinal groove, crossingover to another longitudinal groove at the cross aperture 599, andextending distally along the length of the LEM within the otherlongitudinal groove.

In one example, the auxiliary guide wire 542 may extend proximally alongthe delivery device 500 from a point near the distal end of the deliverydevice to a point near the proximal end of the delivery device and thendistally back to the point near the proximal end of the delivery device.For example, the first portion 542 a of the auxiliary guide wire 542 mayextend through the first side port 534 a of the pusher catheter hub 532and proximally within the pusher catheter 530 and the first auxiliarysheath 540 a as described above. The first portion 542 a of theauxiliary guide wire 542 may exit the pusher catheter 530 and engage theprosthesis (e.g., the prosthesis 110 or the prosthesis 210) as describedabove. For example, the first portion 542 a of the auxiliary guide wire542 may extend further proximally within the lumen 120 of the prosthesis110 and the first auxiliary sheath 540 a. The first portion 542 a of theauxiliary guide wire 542 may exit the prosthesis 110 through the firstfenestration 160, exit the first auxiliary sheath 540 a, and reenter theprosthesis 110 through the first branch 130. The first portion 542 a ofthe auxiliary guide wire 542 may extend further proximally to exit theproximal end 118 of the prosthesis 110 and extend further proximallywithin one of the longitudinal grooves 562 of the nose cone dilator 560.The first portion 542 a of the auxiliary guide wire 542 may extendproximally within a corresponding one of the longitudinal grooves 596 ofthe LEM 590 to the cross aperture 599. At the cross aperture 599, theauxiliary guide wire 542 may cross over from one longitudinal groove 596to another longitudinal groove 596.

The second portion 542 b of the auxiliary guide wire 542 may extenddistally from the cross aperture 599 within the longitudinal groove 596of the LEM 590 and then the longitudinal groove 562 of the nose conedilator 560. The second portion 542 b of the auxiliary guide wire 542may engage the prosthesis (e.g., the prosthesis 110 or the prosthesis210) as described above. For example, the second portion 542 b of theauxiliary guide wire 542 may enter the lumen 120 of the prosthesis 110,extend further distally within the prosthesis, exit the prosthesisthrough the second branch 140, and extend distally external of theprosthesis. The second portion 542 b of the auxiliary guide wire 542 mayenter the second auxiliary sheath 540 b, reenter the prosthesis 110through the second fenestration 170, and extend further distally outthrough the distal end 119 of the prosthesis. The second portion 542 bof the auxiliary guide wire 542 may enter the pusher catheter 530 andextend further distally within the pusher catheter 530 and the secondauxiliary sheath 540 b, and exit the pusher catheter through the sideport 534 b of the pusher catheter hub 532. In this manner, the singleauxiliary guide wire 542 may extend from the pusher catheter hub 532 toa point near the proximal end of the LEM 590 and back to the pushercatheter hub. In other examples, two separate auxiliary guide wires maybe substituted for the first and second portions, respectively, of theauxiliary guide wire 542.

Using a single auxiliary guide wire 542 may aid in retaining the LEM 590in engagement with the nose cone dilator 560 as described below. Using asingle auxiliary guide wire 542 also may eliminate the presence of guidewire ends near the proximal end of the delivery device. This may enhancethe safety of the delivery device by eliminating potentially sharp guidewire ends that may otherwise be present near the proximal tip of thedevice. The auxiliary guide wire 542 also may pass through each of thefirst and second branches 130, 140 and the first and secondfenestrations 160, 170 of the prosthesis 110 to aid in cannulating eachof the first and second branches and the first and second fenestrationswith branch prostheses upon deployment of the prosthesis 110 as furtherdescribed below.

FIG. 11G shows a portion of the proximal end of another embodiment ofthe LEM 590. In this embodiment, the same reference numerals are usedfor features corresponding to those shown in FIGS. 11-11E. FIG. 11Hshows a transverse cross-sectional view taken along line 11H-11H′ ofFIG. 11G. In this embodiment, the LEM 590 may include one or morelongitudinal apertures 596 a, as opposed to the longitudinal grooves 596described above. For example, two longitudinal apertures 596 a mayextend generally longitudinally within the dilator 594 of the LEM 590from the distal end of the dilator to a point near the proximal end ofthe dilator. The auxiliary guide wire 542 may be received within thelongitudinal apertures 596 a generally as described above with referenceto the longitudinal grooves 596.

FIG. 11I is a transverse cross-sectional view of a proximal portion ofone embodiment of the LEM 590 taken along line 11I-11I′ of FIG. 11G. Inthis embodiment, the LEM 590 may include one or more longitudinalapertures 596 a generally as described above in reference to FIGS.11G-11H. Near the proximal end 595 of the dilator 594 of the LEM 590, ascallop 599 a may be cut into the LEM to expose two longitudinalapertures 596 a. The scallop 599 a may provide a pathway connecting thetwo longitudinal apertures 596 a through the dilator 594. This mayenable the auxiliary guide wire 542 to cross over from one longitudinalaperture 596 a to another longitudinal aperture at the scallop 599 a. Bycrossing over from one longitudinal aperture 596 a to anotherlongitudinal aperture, the auxiliary guide wire 542 may be capable ofextending proximally along the length of the LEM 590 within onelongitudinal aperture, crossing over to another longitudinal aperture atthe scallop 599 a, and extending distally along the length of the LEMwithin the other longitudinal aperture.

A friction fit between the tapered tip 566 of the dilator 560 and theLEM 590 may be achieved by a flexible sleeve 632 as shown in FIG. 12A.The flexible sleeve 632 may be affixed to the outer sheath 592 of theLEM 590 and may extend distally from the LEM to engage the proximal end566 of the nose cone dilator 560. The flexible sleeve 632 and the nosecone dilator 560 may be retained in engagement by friction. When the LEM590 is to be removed from the nose cone dilator 560 as described below,a pull on the LEM from the proximal end of the LEM may be sufficient torelease the LEM from the nose cone dilator.

In an alternative embodiment, the LEM 590 and the nose cone dilator 560may be retained in engagement by a trigger wire system as shown in FIG.12B. In this embodiment, the delivery device 500 may include a triggerwire 634 which may extend within the nose cone dilator 560. The triggerwire 634 may exit the nose cone dilator 560 through an elongate aperture561 in the nose cone dilator. The trigger wire 634 may extend along anouter surface of the outer sheath 592 of the LEM 590, through anaperture 591 in the outer sheath, and back into the nose cone dilator560 through an aperture 563. In this manner, the trigger wire 634 mayengage each of the nose cone dilator 560 and the sheath 592 of the LEM590 to retain the LEM in place relative to the nose cone dilator. Thetrigger wire 634 may extend distally to a trigger wire release mechanism512 on the handle 510 of the delivery device 500. When the trigger wire634 is withdrawn by activation of the trigger wire release mechanism 512during a deployment procedure, the outer sheath 592 may be removed fromthe nose cone dilator 560.

In yet another alternative embodiment, the LEM 590 and the nose conedilator 560 may be retained in engagement as shown in FIG. 12C. In, thisembodiment, the distal end of the dilator 594 of the LEM 590 may beconfigured to fit within a proximal recess 565 formed in the proximalend of the nose cone dilator 560. The outer sheath 592 of the LEM 590may include a slightly flared portion 593 near the distal end of theouter sheath. The flared portion 593 of the outer sheath 592 may fitover the proximal end of the nose cone dilator 560.

Thus, in this embodiment, the distal end of the dilator 594 of the LEM590 may be received by and retained in the proximal recess 565 of thenose cone dilator 560 by the friction fit between the distal end of thedilator 594 of the LEM 590 in the proximal recess 565 and between thedistal end of the sheath 592 of the LEM and the nose cone dilator.Additionally, opposite ends of the auxiliary guide wire 542 may belocked at the handle 510, and the auxiliary guide wire may cross overwithin the LEM 590 as described above. This may prevent the LEM 590 frommoving in a proximal direction relative to the nose cone dilator 560.

In still another alternative embodiment, the LEM 590 and the nose conedilator 560 may be retained in engagement as shown in FIG. 12D. In thisembodiment, the distal end of the dilator 594 of the LEM 590 may beconfigured to fit within the proximal recess 565 formed in the proximalend of the nose cone dilator 560 as described above with reference toFIG. 12C. The longitudinal grooves 596 of the dilator 594 of the LEM 590may terminate at a point 597 proximal of the distal end of the dilator594. A sleeve 595 may surround at least a portion of the nose conedilator 560 and the outer sheath 592 of the LEM 590. The sleeve 595 maybe shrink fitted and/or glued to the outer sheath 592 and the nose conedilator 560. The sleeve 595 may retain the auxiliary guide wire 542within the longitudinal grooves 596 of the dilator 594. A hole 561 mayextend through the nose cone dilator 560 and into the proximal recess565 as shown in FIG. 12D. A trigger wire 634 may extend from the handle510 of the delivery device 500, through the hole 561, and into alongitudinal groove 596 just proximal of the end 597 of the groove.

Thus, in this embodiment, the distal end of the dilator 594 of the LEM590 may be received by and retained in the proximal recess 565 of thenose cone dilator 560 by the friction fit between the distal end of thedilator 594 of the LEM 590 in the proximal recess 565. Additionally, thetrigger wire 634 may be positioned against the end 597 of thelongitudinal groove 596 to interfere with proximal movement of the LEM590 relative to the nose cone dilator 560. Additionally, opposite endsof the auxiliary guide wire 542 may be locked at the handle 510, and theauxiliary guide wire may cross over within the LEM 590 as describedabove. This may prevent the LEM 590 from moving in a proximal directionrelative to the nose cone dilator 560.

In another alternative embodiment, the LEM 590 and the nose cone dilator560 may be retained in engagement as shown in FIGS. 13A-13B. In thisembodiment, the distal end of the dilator 594 of the LEM 590 may beconfigured to fit within the proximal recess 565 formed in the proximalend of the nose cone dilator 560 as described above with reference toFIG. 12C. The longitudinal grooves 596 of the dilator 594 of the LEM 590may terminate at the point 597 proximal of the distal end of the dilator594 as described above with reference to FIG. 12D. A sleeve 732 maysurround at least a portion of the outer sheath 592 of the LEM 590. Thesleeve 732 may be shrink fitted and/or glued to the outer sheath 592near the distal end of the outer sheath. The sleeve 732 may include anelongate tab 733 which may extend distally along the nose cone dilator560 when the distal end of the dilator 594 of the LEM 590 is receivedwithin the proximal recess 565 in the nose cone dilator. A hole 735 maybe formed near the distal end of the elongate tab 733. A correspondinghole 561 may extend through the nose cone dilator 560 and into theproximal recess 565 as shown in FIG. 13B. A trigger wire 734 may extendfrom the handle 510 of the delivery device 500, through the hole 735 andthe corresponding hole 561, and into a longitudinal groove 596 justproximal of the end 597 of the groove.

Thus, in this embodiment, the distal end of the dilator 594 of the LEM590 may be received by and retained in the proximal recess 565 of thenose cone dilator 560 by the friction fit between the distal end of thedilator 594 of the LEM 590 in the proximal recess 565. Additionally, thetrigger wire 734 may be positioned against the end 597 of thelongitudinal groove 596 to interfere with proximal movement of the LEM590 relative to the nose cone dilator 560. Additionally, opposite endsof the auxiliary guide wire 542 may be locked at the handle 510, and theauxiliary guide wire may cross over within the LEM 590 as describedabove. This may prevent the LEM 590 from moving in a proximal directionrelative to the nose cone dilator.

Referring now to FIGS. 14A-18L, exemplary method steps for using aprosthesis (e.g., the prosthesis 110, shown in FIGS. 1-2, or theprosthesis 210, shown in FIGS. 8-9) to treat a condition in the area ofa patient's thoracoabdominal aorta and/or branch vessels are shown anddescribed. FIGS. 14A-14F illustrate exemplary method steps fordelivering the prosthesis to the patient's thoracoabdominal aorta. In afirst step, the prosthesis may be provided with one or more auxiliaryguide wires (e.g., the auxiliary guide wire 542) coupled to the graft inthe preloaded configuration as described above. FIG. 14A shows aschematic view of a portion of the vasculature of a human body. Thevasculature shown includes an aorta 860 extending from a heart 862 overa thoracic arch 864 to an aortic bifurcation 866. At the aorticbifurcation 866, iliac arteries 868 a, 868 b extend down to respectivefemoral arteries 870 a, 870 b. A brachiocephalic artery 872, a carotidartery 874, and a left subclavian artery 876 extend from the thoracicarch 864. Renal arteries 877, 878 extend from the aorta 860, and asuperior mesenteric artery 879 and a celiac artery 880 extend from theaorta 860 just proximal of the renal arteries 877, 878. These fourarteries can generally be referred to as the visceral arteries. Theaorta 860 is depicted with an aneurism 882, which has occurred in theregion of the visceral arteries. It may be desirable to deploy aprosthesis, such as a stent graft, into the aorta 860 to span theaneurism 882 while, at the same time, allowing catheterization and sidearm deployment into the renal arteries 877, 878, the superior mesentericartery 879, and the celiac artery 880.

In a first stage of the process, as shown in FIG. 14A, a guide wire 890may be introduced through a femoral puncture 891 in the femoral artery870 b. The guide wire 890 may be advanced proximally through the femoralartery 870 b into the iliac artery 868 b and into the aorta 860. Theguide wire 890 may be advanced proximally until the proximal end of theguide wire is positioned just proximal of the visceral arteries. Abrachial access sheath 892 may be introduced through a brachial puncture893 in the left subclavian artery 876. The brachial access sheath 892may include a. sheath hub 894. In one example, the brachial accesssheath 892 may have a size of about 12 Fr. The brachial access sheath892 may be advanced through the left subclavian artery 876 and into thedescending aorta 860 a. In any of the examples described herein, theaccess sheath 892 may be introduced through the right brachial artery,the left brachial artery, the axillary artery, or any other suitableaccess point. Such alternative access points are contemplated by andwithin the scope of this disclosure.

As shown in FIG. 14B, a grasper device 896 with a snare 898 may beintroduced through the sheath hub 894 and down the brachial accesssheath 892. The snare 898 may engage the proximal end of the guide wire890. The snare 898 may be used to draw the guide wire 890 through thebrachial access sheath 892 as shown in FIG. 14C. The guide wire 890 maybe drawn out through the sheath hub 894 of the brachial access sheath892 to establish a femoral to subclavian through-and-through wire.

In an alternative embodiment, the grasper device 896 with the snare 898may be introduced through the femoral puncture 891, and the guide wire890 may be introduced through the brachial puncture 893. The snare 898may be used to engage the guide wire 890 and draw the guide wire throughthe femoral puncture 891 to establish the femoral to subclavianthrough-and-through wire. This approach may be beneficial for treating acondition such as aortic dissection because it may be easier to keep theguide wire in the true lumen when the guide wire is introduced from thebrachial puncture as opposed to the femoral puncture.

The proximal end of the LEM 590 of the deployment device 500 may beintroduced into the femoral artery 870 b through the femoral puncture891. The deployment device 500 may be tracked over the guide wire 890until the proximal end of the LEM 590 emerges from the sheath hub 894 ofthe brachial access sheath 892 as shown in FIG. 14D. At this stage, thenose cone dilator 560 of the delivery device 500 may be positioned suchthat the prosthesis retained within the sheath 550 is in proximity toits desired final position within the aorta 860.

In a next stage, the ends of the auxiliary guide wire 542 may bereleased from the handle 510 of the delivery device 500. The auxiliaryguide wire 542 may be separated slightly from the LEM 590 and severed toprovide two separate guide wires. The auxiliary guide wire 542 may besevered near the cross aperture 599. In other words, the singleauxiliary guide wire 542 may be severed between the first portion 542 aand the second portion 542 b so that the first and second portions ofthe auxiliary guide wire form two separate wires. In other examples,first and second wire segments may be used in place of the auxiliaryguide wire 542.

The LEM 590 may be removed from selective engagement with the proximalend of the nose cone dilator 560. The LEM 590 may be removed fromselective engagement with the nose cone dilator 560 by pulling theproximal end of the LEM 590 extending from the sheath hub 894 of thebrachial access sheath 892. The LEM 590 may be removed through thesheath hub 894 of the brachial access sheath 892 such that the auxiliaryguide wire 542 remains in place with each of the first and secondportions 542 a, 542 b of the auxiliary guide wire extending out throughthe sheath hub 894 as shown in FIG. 14E. At this stage, the firstportion 542 a of the auxiliary guide wire 542 may providethrough-and-through access from the femoral puncture 891 and thebrachial puncture 893. Similarly, the second portion 142 b of theauxiliary guide wire 142 may provide through-and-through access from thefemoral puncture 891 and the brachial puncture 893.

In a next stage, the sheath hub 552 of the delivery device 500 may beretracted to partially withdraw the sheath 550 from the prosthesis asshown in FIG. 14F. Although FIG. 14F shows the delivery device 500 withthe prosthesis 110 loaded thereon, the delivery device 500 may be usedto deliver the prosthesis 210, or another prosthesis, in a similarmanner. Upon partial withdrawal of the sheath 550, the prosthesis may atleast partially expand from the reduced diameter delivery configuration.The prosthesis, or a portion of the prosthesis, may be retained in apartially expanded configuration to enable repositioning of theprosthesis within the aorta 860 prior to complete expansion of theprosthesis. In other words, the prosthesis, or a portion of theprosthesis, may be retained to prevent the prosthesis from expanding toa fully expanded configuration. In the partially expanded configuration,the retained portion of the prosthesis may have a diameter that is lessthan the diameter of the portion of the prosthesis in the fully expandedconfiguration. The prosthesis may be retained using any suitable methodknown in the art. In one example, the prosthesis may be retained by oneor more diameter reducing ties. Each diameter reducing tie may includeone or more filamentary strands extending at least partiallycircumferentially around the prosthesis. Each strand may engage aportion of the prosthesis and may be looped around a trigger wire toprevent expansion of the prosthesis. The diameter reducing ties may beconfigured generally as described in U.S. Patent Application Pub. Nos.2004/0098084 by Hartley et al., 2006/0004433 by Greenberg et al.,2007/0043425 by Hartley et al., 2007/0142896 by Anderson et al.,2008/0114438 by Hartley at al., or 2008/0294234 by Hartley et al. Inanother example, the prosthesis may be retained by one or morefilamentary strands circumscribing the prosthesis. The strands may beengaged by one or more trigger wires to maintain tension on the strandsto retain the prosthesis from expanding. In any of these examples, theproximal end, the distal end, and/or any other portion of the prosthesismay be retained from expanding to the fully expanded configuration.Additionally, or alternatively, the proximal end of the prosthesis maybe retained (e.g., by one or more trigger wires) to form the lobes ofgraft material as described above. Such retention of the proximal end ofthe prosthesis may enable repositioning of the prosthesis within theaorta 860 prior to complete expansion of the prosthesis. Additionally,or alternatively, the distal end of the prosthesis may be retainedwithin the sheath to prevent expansion of the distal end of theprosthesis. Such retention of the distal end of the prosthesis mayenable repositioning of the prosthesis within the aorta 860 prior tocomplete expansion of the prosthesis.

FIGS. 15A-15G illustrate exemplary method steps for deploying theprosthesis 110. The first portion 542 a of the auxiliary guide wire 542may provide clear access to the first branch 130 of the prosthesis 110from the brachial puncture 893 and clear access to the firstfenestration 160 of the prosthesis from the femoral puncture 891 asfurther described below. The second portion 542 b of the auxiliary guidewire 542 may provide clear access to the second branch 140 of theprosthesis 110 from the brachial puncture 893 and clear access to thesecond fenestration 170 of the prosthesis from the femoral puncture 891also as further described below.

A sheath 810 may be advanced over the first portion 542 a of theauxiliary guide wire 542, through the sheath hub 894, and through thebrachial access sheath 892. The sheath 810 may be advanced from thebrachial artery distally down the aorta 860. In one example, the sheath810 may have a size ranging from about 6 Fr to about 7 Fr. In anotherexample, the sheath 810 may have a size ranging from about 8 Fr to about10 Fr. A dilator (not shown) may be positioned within the sheath 810 toaid in advancing the sheath 810 through the brachial access sheath 892.The sheath 810 may be advanced distally through the lumen 135 of thefirst branch 130 of the prosthesis 110, and disposed adjacent to theceliac artery 880 as shown in FIG. 15A. If a dilator is used, then afterdesired placement of the sheath 810, the dilator may be withdrawnproximally out of the patient's anatomy via the brachial artery, leavingthe sheath 810 in place near the celiac artery 880.

In a next stage, a wire guide 812 a may be introduced via the sheath810. The wire guide 812 a may be advanced within the sheath 810, withinthe prosthesis 110, and out the first branch 130 to exit the sheath 810and enter the celiac artery 880 as shown in FIG. 15B. The wire guide 812a may be received within a catheter 813, which may be introduced withthe wire guide 812 a via the sheath 810. The catheter 813 may aid inguiding the wire guide 812 a into the celiac artery 880. To that end,the catheter 813 may be advanced such that a distal end of the catheter813 is positioned proximate the ostium of the celiac artery 880 as shownin FIG. 15B. The wire guide 812 a and the catheter 813 may be furtheradvanced into the celiac artery 880 as shown in FIG. 15C.

A wire guide 814 a may be introduced via the first auxiliary sheath 540a. The wire guide 814 a may be introduced into the first auxiliarysheath 540 a at the pusher catheter hub 532. Introduction of a sheath(e.g., the sheath 810) may be unnecessary because the wire guide 814 amay be introduced directly into the first auxiliary sheath 540 a, whichmay be preloaded into the prosthesis 110 as described above. The wireguide 814 a may be advanced within the first auxiliary sheath 540 a,through the side port 534 a of the pusher catheter hub 532, and throughthe pusher catheter 530. The wire guide 814 a may be advanced within theprosthesis 110 and out the first fenestration 160 to exit the firstauxiliary sheath 540 a and enter the left renal artery 878 as shown inFIG. 15B. The wire guide 814 a may be received within a catheter 815,which may be introduced with the wire guide 814 a via the firstauxiliary sheath 540 a. The catheter 815 may aid in guiding the wireguide 814 a into the left renal artery 878. To that end, the catheter815 may be advanced such that a proximal end of the catheter 815 ispositioned proximate the ostium of the left renal artery 878 as shown inFIG. 15B. The wire guide 814 a and the catheter 815 may be furtheradvanced into the left renal artery 878 as shown in FIG. 15C.

In one example, the wire guide 812 a and the catheter 813 may beintroduced to cannulate the celiac artery 880 before the wire guide 814a and the catheter 815 are introduced to cannulate the left renal artery878. In another example, the wire guide 814 a and the catheter 815 maybe introduced to cannulate the left renal artery 878 before the wireguide 812 a and the catheter 813 are introduced to cannulate the celiacartery 880. In yet another example, the wire guide 812 a and thecatheter 813 and the wire guide 814 a and the catheter 815 may beintroduced substantially simultaneously to cannulate the celiac artery880 and the left renal artery 878, respectively, at substantially thesame time. In any of the examples described herein, the various visceralarteries may be cannulated in any suitable sequence, and side branchprostheses may be deployed into the various visceral arteries in anysuitable sequence.

The wire guide 812 a may be retracted proximally relative to thecatheter 813 and the sheath 810 to remove the wire guide 812 a from thepatient's body. A wire guide 812 b may be introduced through thecatheter 813 and the sheath 810 in a distal direction from the brachialartery and ultimately into the celiac artery 880 as shown in FIG. 15D.In other words, the wire guide 812 a may be replaced with the wire guide812 b. The wire guide 812 b may have a stiffness that is greater than astiffness of the wire guide 812 a. The wire guide 814 a may be retracteddistally relative to the catheter 815 and the first auxiliary sheath 540a to remove the wire guide 814 a from the patient's body. A wire guide814 b may be introduced through the catheter 815 and the first auxiliarysheath 540 a in a proximal direction from the femoral artery andultimately into the left renal artery 878 as shown in FIG. 15D. In otherwords, the wire guide 814 a may be replaced with the wire guide 814 b.The wire guide 814 b may have a stiffness that is greater than astiffness of the wire guide 814 a.

The position of the first portion 542 a of the auxiliary guide wire 542in the first branch 130 and the first fenestration 160 may aid incannulation of the celiac artery 880 and the left renal artery 878. Forexample, the first portion 542 a of the auxiliary guide wire 542 mayprovide stability to the prosthesis 110 during introduction or movementof various components (e.g., sheaths, wire guides, or catheters) asdescribed herein. With the catheter 813 and the wire guide 812 b inplace within the celiac artery 880 and the catheter 815 and the wireguide 814 b in place within the left renal artery 878, the first portion542 a of the auxiliary guide wire 542 may be removed from the patient'sbody. The first portion 542 a of the auxiliary guide wire 542 may beretracted distally away from the brachial artery and removed from thepatient's body via the femoral artery. Alternatively, the first portion542 a of the auxiliary guide wire 542 may be retracted proximally awayfrom the femoral artery and removed from the patient's body via thebrachial artery.

The catheter 813 may be retracted proximally relative to the sheath 810and removed from the patient's body. The wire guide 812 b may remain inplace within the celiac artery 880 as shown in FIG. 15E. The firstauxiliary sheath 540 a may be advanced proximally over the catheter 815and the wire guide 814 b and into the left renal artery 878 as shown inFIG. 15D. With the first auxiliary sheath 540 a in place within the leftrenal artery 878, the catheter 815 may be retracted distally relative tothe first auxiliary sheath 540 a and removed from the patient's body.The first auxiliary sheath 540 a and the wire guide 814 b may remain inplace within the left renal artery 878 as shown in FIG. 15E. Theposition of the wire guide 812 b in the celiac artery 880 may enabledelivery of a side branch prosthesis into the celiac artery 880 usingany suitable endovascular delivery technique. The position of the firstauxiliary sheath 540 a and the wire guide 814 b in the left renal artery878 may enable delivery of a side branch prosthesis into the left renalartery 878 using any suitable endovascular technique.

In a next stage, a side branch prosthesis 820 may be deployed in theceliac artery 880. The side branch prosthesis 820 (and the side branchprostheses 830, 840, 850 described below) may be formed of biocompatiblematerials and may be configured as covered stents, Alternatively, theside branch prostheses may be configured as bare stents. The covered orbare stents may be either self-expanding or balloon expandable. In oneembodiment, a side branch prosthesis may have both self-expanding andballoon expandable components. For example, a side branch prosthesis mayhave an end for placement within a branch or fenestration of theprosthesis that is, upon deployment, either self-expanding or balloonexpandable. By way of example and without limitation, the side branchprostheses may include the Fluency® Plus Vascular Stent Graft from BardPeripheral Vascular, Helsingborg, Sweden, or the Jostent® PeripheralStent Graft from Abbott Vascular, Abbott Park, Ill.

The side branch prosthesis 820 may be compressed into a delivery stateand delivered using a suitable deployment system or introducer. Forexample, an introducer 816 may include a delivery catheter and an outersheath. In another example, the outer sheath may be omitted from theintroducer. The side branch prosthesis 820 may be radially compressedonto the delivery catheter of the introducer 816 and covered by theouter sheath. The introducer 816 may be introduced over the wire guide812 b and through the sheath 810 in a distal direction from the brachialartery and ultimately into the celiac artery 880 as shown in FIG. 15F.The side branch prosthesis 820 may be deployed from the introducer 816(e.g., by retraction of the sheath of the introducer). Upon deployment,the side branch prosthesis 820 may extend from the first branch 130 ofthe prosthesis 110 into the celiac artery 880 as shown in FIG. 15F. Theside branch prosthesis 820 and the first branch 130 of the prosthesis110 may be mated such that there is a suitable tromboning connection,preferably with a 1.5 to 2 cm overlap and a 1 mm or less difference indiameter at the interconnection. Optionally, the devices may be expandedfor about 30 seconds using a suitably sized balloon dilation catheter.At this time, the side branch prosthesis 820 may provide patent fluidflow through the prosthesis 110 into the celiac artery 880. Theintroducer 816, the wire guide 812 b, and the sheath 810 then may bewithdrawn proximally out of the patient's body via the brachial artery.

A side branch prosthesis 830 may be deployed in the left renal artery878. The side branch prosthesis 830 may be compressed into a deliverystate and delivered using a suitable deployment system or introducer.For example, the side branch prosthesis 830 may be delivered using anintroducer 818, which may be configured generally as described abovewith reference to the introducer 816. The introducer 818 may beintroduced over the wire guide 814 b and through the first auxiliarysheath 540 a in a proximal direction from the femoral artery andultimately into the left renal artery 878 as shown in FIG. 15E. With theintroducer 818 in place within the left renal artery 878, the firstauxiliary sheath 540 a may be retracted distally relative to theintroducer 818 and removed from the left renal artery. The side branchprosthesis 830 may be deployed from the introducer 818. Upon deployment,the side branch prosthesis 830 may extend from the first fenestration160 into the left renal artery 878 as shown in FIG. 15F. Upondeployment, the side branch prosthesis 830 and the first fenestration160 may be mated. Optionally, the devices may be expanded for about 30seconds using a suitably sized balloon dilation catheter. At this time,the side branch prosthesis 830 may provide patent fluid flow through theprosthesis 110 into the left renal artery 878. The introducer 818, thewire guide 814 b, and the first auxiliary sheath 540 a then may bewithdrawn distally out of the patient's body via the femoral artery.

In one example, the side branch prosthesis 820 may be deployed in theceliac artery 880 before the side branch prosthesis 830 is deployed inthe left renal artery 878. In another example, the side branchprosthesis 830 may be deployed in the left renal artery 878 before theside branch prosthesis 820 is deployed in the celiac artery 880. In yetanother example, the side branch prosthesis 820 and the side branchprosthesis 830 may be deployed substantially simultaneously in theceliac artery 880 and the left renal artery 878, respectively, atsubstantially the same time.

Side branch prostheses may be deployed within the second branch 140 andthe second fenestration 170 in the same manner as described above inreference to the first branch 130 and the first fenestration 160. Forexample, in a next stage, a first sheath, which may be configured asdescribed above with reference to the sheath 810, may be advanced overthe second portion 542 b of the auxiliary guide wire 542, through thesheath hub 894, and through the brachial access sheath 892. In otherexamples, the sheath 810 may be substituted for the first sheath. Thefirst sheath may be advanced from the brachial artery distally down theaorta 860. The first sheath may be advanced distally through the lumen145 of the second branch 140, and disposed adjacent to the superiormesenteric artery 879.

In a next stage, a first wire guide, which may be configured asdescribed above with reference to the wire guide 812 a, may beintroduced via the first sheath. The first wire guide may be advancedwithin the first sheath, within the prosthesis 110, and out the secondbranch 140 to exit the first sheath and enter the superior mesentericartery 879. In other examples, the wire guide 812 a may be substitutedfor the first wire guide. The first wire guide may be received within afirst catheter, which may be configured as described above withreference to the catheter 813. The first catheter may be introduced withthe first wire guide via the first sheath. The first catheter may beadvanced such that a distal end of the first catheter is positionedproximate the ostium of the superior mesenteric artery 879. The firstwire guide and the first catheter may be further advanced into thesuperior mesenteric artery 879.

A second wire guide, which may be configured as described above withreference to the wire guide 814 a, may be introduced via the secondauxiliary sheath 540 b. The second wire guide may be introduced into thesecond auxiliary sheath 540 b at the pusher catheter hub 532.Introduction of a sheath (e.g., the sheath 810) may be unnecessarybecause the second wire guide may be introduced directly into the secondauxiliary sheath 540 b, which may be preloaded into the prosthesis 110as described above. The second wire guide may be advanced within thesecond auxiliary sheath 540 b, through the side port 534 b of the pushercatheter hub 532, and through the pusher catheter 530. The second wireguide may be advanced within the prosthesis 100 and out the secondfenestration 170 to exit the second auxiliary sheath 540 b and enter theright renal artery 877. In other examples, the wire guide 814 a may besubstituted for the second wire guide. The second wire guide may bereceived within a second catheter, which may be configured as describedabove with reference to the catheter 815. The second catheter may beintroduced with the second wire guide via the second auxiliary sheath540 b. The second catheter may be advanced such that a proximal end ofthe second catheter is positioned proximate the ostium of the rightrenal artery 877. The second wire guide and the second catheter may befurther advanced into the right renal artery 877.

In one example, the first wire guide and the first catheter may beintroduced to cannulate the superior mesenteric artery 879 before thesecond wire guide and the second catheter are introduced to cannulatethe right renal artery 877. In another example, the second wire guideand the second catheter may be introduced to cannulate the right renalartery 877 before the first wire guide and the first catheter areintroduced to cannulate the superior mesenteric artery 879. In yetanother example, the first wire guide and the first catheter and thesecond wire guide and the second catheter may be introducedsubstantially simultaneously to cannulate the superior mesenteric artery879 and the right renal artery 877, respectively, at substantially thesame time.

The first wire guide may be removed from the patient's body and replacedwith a third wire guide, which may be configured as described above withreference to the wire guide 812 b. The second wire guide may be removedfrom the patient's body and replaced with a fourth wire guide, which maybe configured as described above with reference to the wire guide 814 b.With the first catheter and the third wire guide in place within thesuperior mesenteric artery 879 and the second catheter and the fourthwire guide in place within the right renal artery 877, the secondportion 542 b of the auxiliary guide wire 542 may be removed from thepatient's body.

The first catheter may be removed from the patient's body while thethird wire guide may remain in place within the superior mesentericartery 879. The second auxiliary sheath 540 b may be advanced proximallyover the second catheter and the fourth wire guide and into the rightrenal artery 877. The second catheter may be removed from the patient'sbody while the second auxiliary sheath 540 b and the fourth wire guidemay remain in place within the right renal artery 877. At this stage,the positions of the third wire guide in the superior mesenteric artery879 and the second auxiliary sheath 540 b and the fourth wire guide inthe right renal artery 877 may enable delivery of a side branchprosthesis into each of the superior mesenteric artery 879 and the rightrenal artery 877 using any suitable endovascular technique.

In a next stage, a side branch prosthesis 840 may be deployed in thesuperior mesenteric artery 879. The side branch prosthesis 840 may becompressed into a delivery state and delivered using a first introducer,which may be configured as described above with reference to theintroducer 816. The first introducer 816 may be introduced over thethird wire guide and through the first sheath in a distal direction fromthe brachial artery and ultimately into the superior mesenteric artery879. The side branch prosthesis 840 may be deployed from the firstintroducer. Upon deployment, the side branch prosthesis 840 may extendfrom the second branch 140 of the prosthesis 110 into the superiormesenteric artery 879 as shown in FIG. 15G. The side branch prosthesis840 and the second branch 140 of the prosthesis 110 may be mated suchthat there is a suitable tromboning connection as described above.Optionally, the devices may be expanded for about 30 seconds using asuitably sized balloon dilation catheter. At this time, the side branchprosthesis 840 may provide patent fluid flow through the prosthesis 110into the superior mesenteric artery 879. The first introducer, the thirdwire guide, and the first sheath then may be withdrawn proximally out ofthe patient's body via the brachial artery.

A side branch prosthesis 850 may be deployed in the right renal artery877. The side branch prosthesis 850 may be compressed into a deliverystate and delivered using a second introducer, which may be configuredas described above with reference to the introducer 818. The secondintroducer may be introduced over the fourth wire guide and through thesecond auxiliary sheath 540 b in a proximal direction from the femoralartery and ultimately into the right renal artery 877. The side branchprosthesis 850 may be deployed from the second introducer. Upondeployment, the side branch prosthesis 850 may extend from the secondfenestration 170 into the right renal artery 877 as shown in FIG. 15G.Upon deployment, the side branch prosthesis 850 and the secondfenestration 170 may be mated. Optionally, the devices may be expandedfor about 30 seconds using a suitably sized balloon dilation catheter.At this time, the side branch prosthesis 850 may provide patent fluidflow through the prosthesis 110 into the right renal artery 877. Thesecond introducer, the fourth wire guide, and the second auxiliarysheath 540 b then may be withdrawn distally out of the patient's bodyvia the femoral artery.

In one example, the side branch prosthesis 840 may be deployed in thesuperior mesenteric artery 879 before the side branch prosthesis 850 isdeployed in the right renal artery 877. In another example, the sidebranch prosthesis 850 may be deployed in the right renal artery 877before the side branch prosthesis 840 is deployed in the superiormesenteric artery 879. In yet another example, the side branchprosthesis 840 and the side branch prosthesis 850 may be deployedsubstantially simultaneously in the superior mesenteric artery 879 andthe right renal artery 877, respectively, at substantially the sametime.

The configuration and placement of the various branches 130, 140 andfenestrations 160, 170 along the graft 112 may provide the ability tomanipulate the first and second portions 542 a, 542 b or the auxiliaryguide wire 542 and delivery components in a manner that will allow forrelatively quick delivery of four different side branch prostheses. Thepreloaded system provided by the present embodiments may save multiplesteps and significant time during a surgical operation.

The access provided by the auxiliary guide wire 542 into each of theopenings in the prosthesis 110 corresponding to each of the visceralarteries may enable multiple side branch prostheses to be deployedsubstantially simultaneously. For example, one physician may deploy sidebranch prostheses into the celiac and/or superior mesenteric arteriesfrom the brachial puncture 893 while a second physician deploys sidebranch prostheses into the left and/or right renal arteries from thefemoral puncture 891. In another example, a first physician may deploy aside branch prosthesis into the celiac artery 880 from the brachialpuncture 893 while a second physician may deploy a side branchprosthesis into the superior mesenteric artery 879 from the brachialpuncture. At the same time, a third physician may deploy a side branchprosthesis into the left renal artery 878 from the femoral puncture 891while a fourth physician may deploy a side branch prosthesis into theright renal artery 877. In this example, four physicians may deploy fourside branch prostheses (one in each of the visceral arteries)substantially simultaneously. The ability to deploy side branchprostheses from both ends of the delivery device 500 (e.g., from thefemoral access and the brachial access) substantially simultaneously mayreduce the amount of time that may be required to perform a deploymentprocedure. Multiple access sites may allow for substantiallysimultaneous cannulation of vessels, which may decrease the timerequired to perform a procedure and the patient's exposure to x-rays orfluoroscopy contrast.

Once a side branch prosthesis has been deployed into each of thevisceral arteries, the sheath 550 may be further retracted to releasethe distal end 119 of the prosthesis 110, and the proximal retentionmechanisms may be activated to release the proximal end 118 of theprosthesis. Releasing the distal end 119 and the proximal end 118 of theprosthesis 110 may enable the prosthesis to expand to a fully expandeddeployed configuration as shown in FIG. 15G. The delivery device 500then may be retracted through the femoral puncture 891, and the brachialaccess sheath 892 may be retracted through the brachial puncture 893.

As shown in FIGS. 16-17, the fenestrations 160, 170 of the prosthesis110 may not align completely with the branch vessels of the patient. Thefenestrations may not align because, for example, the patient's leftrenal artery 878 may be may be positioned higher than the patient'sright renal artery 877, or vice versa. To accommodate placement of theside branch prostheses 830, 850 into the left and right renal arteries878, 877, the fenestrations 160, 170 may be configured as pivotfenestrations as described above to provide flexibility and ability topivot so that the side branch prostheses 830, 850 may be deployed intothe left and right renal arteries 878, 877.

FIGS. 16-17 show the side branch prosthesis 830 deployed in the leftrenal artery 878 in greater detail. In one example, shown in FIG. 16,the side branch prosthesis 830 may be deployed within the left renalartery 878 which may be positioned lower than its corresponding rightrenal artery 877. The first fenestration 160 may be configured to pivotto allow the side branch prosthesis 830 to be positioned at an anglerelative to the graft 112. The ability to angle the side branchprosthesis 830 may allow an off-the-shelf prosthesis, such as theprosthesis 110, to be used to treat a patient whose anatomy does notalign completely with the first fenestration 160. In another example,shown in FIG. 17, the side branch prosthesis 830 may be deployed withinthe left renal artery 878 which may be positioned higher than itscorresponding right renal artery 877. The fenestration 160 may beconfigured to pivot to accommodate the offset position of the left renalartery 878 and provide access to the left renal artery 878 through theuse of a delivery device, such as a catheter.

Once a catheter is placed within the left renal artery 878, the sidebranch prosthesis 830 may be deployed within the left renal artery 878.The side branch prosthesis 830 may be balloon expandable orself-expandable. In one example, the side branch prosthesis is balloonexpandable. Once the side branch prosthesis 830 is deployed within theleft renal artery 878, the end of the side branch prosthesis remainingwithin the interior surface of the graft 112 may be flared to provide aproper seal between the fenestration 161 and the left renal artery 878.

FIGS. 18A-18L illustrate exemplary method steps for deploying theprosthesis 210. The prosthesis 210 may be positioned within thepatient's aorta 860 as described above with reference to FIGS. 14A-14F.The first portion 542 a of the auxiliary guide wire 542 may provideclear access to the first branch 230 and the third branch 260 of theprosthesis 210 from the brachial puncture 893 as further describedbelow. The second portion 542 b of the auxiliary guide wire 542 mayprovide clear access to the second branch 240 of the prosthesis 210 fromthe brachial puncture 893 and clear access to the fourth branch 170 ofthe prosthesis from the femoral puncture 891 also as further describedbelow.

It should be noted that, in FIGS. 18A-18L, outer surfaces of theprosthesis 210 are not shown as being in contact with inner surfaces ofthe aorta 860 solely for illustrative purposes. In use, the graft 212may be sized and configured so that at least an outer surface of theregion proximal to the tapered portion securely engages an inner surfaceof the aorta 860 to hold the prosthesis 210 in place relative to thevasculature. Additional outer regions of the graft may securely engagethe inner surface of the aorta 860. Optionally, additional modularprostheses may be coupled to the prostheses (e.g., extending into one ormore of the iliac arteries) whereby the modular prostheses have outersurfaces dimensioned to securely engage inner surfaces of the iliacarteries or other vasculature.

Referring now to FIG. 18B, in a next step, a sheath 810 may be advancedover the first portion 542 a of the auxiliary guide wire 542, in adirection from the brachial artery and distally down the aorta 860. Inone example, the sheath 810 comprises a size of about 6 French. Thesheath 810 may be advanced distally through the lumen 235 of the firstbranch 230, through the self-sealing fenestration 250, through the lumen265 of the third branch 260, and toward the right renal artery 877, asdepicted in FIG. 18B. Optionally, a dilator may be used in conjunctionwith the sheath 810 to facilitate advancement of the sheath 810 to theposition shown in FIG. 18B. If a dilator is used, then after desiredplacement of the sheath 810, the dilator may be withdrawn proximally outof the patient's anatomy via the brachial artery, leaving the sheath 810in place near the right renal artery 877.

Referring now to FIG. 18C, at this stage, the first portion 542 a of theauxiliary guide wire 542 can be withdrawn from the brachial artery, andanother wire guide 812 a may be introduced via the sheath 810. The wireguide 812 a may be received within the catheter 813, which may beintroduced with the wire guide 812 a via the sheath 810 as describedabove. The catheter 813 may aid in guiding the wire guide 812 a into theright renal artery 877. To that end, the catheter 813 may be advancedsuch that a distal end of the catheter 813 is positioned proximate theostium of the right renal artery 877, and the wire guide 812 a and thecatheter 813 may be further advanced into the right renal artery 877 asshown in FIG. 18C. In one example, the first portion 542 a of theauxiliary guide wire 542 may remain in place to stabilize the thirdbranch 260 during advancement of the wire guide 812 a and/or thecatheter 813. The wire guide 812 a may be replaced with the wire guide812 b, which may have a stiffness that is greater than a stiffness ofthe wire guide 812 a as described above. The catheter 813 may beretracted proximally relative to the sheath 810 and removed from thepatient's body. The wire guide 812 b may remain in place within theright renal artery 877 as shown in FIG. 18D. The position of the wireguide 812 b in the right renal artery 877 may enable delivery of a sidebranch prosthesis into the right renal artery 877 using any suitableendovascular delivery technique.

The further deployment device 816 can then be introduced via the sheath810 and the wire guide 812 b, such that the deployment device 816 isadvanced through a length of the sheath 810 in a distal direction fromthe brachial artery and ultimately into the right renal artery 877 asshown in FIG. 18D. The deployment device 816 may extend out of thedistal end 264 of the third branch 260 of the prosthesis 210 so that aside branch prosthesis 820 can be deployed to extend from the thirdbranch 260 into the right renal artery 877 as shown in FIG. 18E.

Referring to FIG. 18E, upon deployment from the deployment device 816,the side branch prosthesis 820 and the third branch 260 of theprosthesis 210 may be mated such that there is a suitable tromboningconnection, preferably with a 1.5 to 2 cm overlap and a 1 mm or lessdifference in diameter at the interconnection. Optionally, the devicesmay be expanded for about 30 seconds using a suitably sized balloondilation catheter. At this time, the side branch prosthesis 820 mayprovide patent fluid flow through the graft 212 into the right renalartery 877. The deployment device 816 and the wire guide 812 b may beretracted proximally and removed from the patient's body.

Referring now to FIG. 18F, in a next step, the sheath 810 may beproximally retracted away from the right renal artery 877 and throughthe self-sealing fenestration 250 until the distal end of the sheath 810is positioned just distal to the first branch 230 at a location adjacentto the celiac artery 880. Notably, the self-sealing fenestration 250 maybecome closed without leakage upon removal of various components (e.g.,the first portion 542 a of the auxiliary guide wire 542, the wire guides812 a, 812 b, the deployment device 816, and/or the sheath 810), asexplained above. The wire guide 812 a, or another wire guide, then maybe advanced from the sheath 810 in a distal direction into the celiacartery 880, as shown in FIG. 18F. The wire guide 812 a may be receivedwithin the catheter 813, or another catheter, which may be introducedwith the wire guide 812 a via the sheath 810 as described above. Thecatheter 813 may aid in guiding the wire guide 812 a into the celiacartery 880. To that end, the catheter 813 may be advanced such that thedistal end of the catheter 813 is positioned proximate the ostium of theceliac artery 880, and the wire guide 812 a and the catheter 813 may befurther advanced into the celiac artery 880 as shown in FIG. 18F. Thewire guide 812 a may be replaced with the wire guide 812 b, or anotherwire guide, which may have a stiffness that is greater than a stiffnessof the wire guide 812 a as described above. The catheter 813 may beretracted proximally relative to the sheath 810 and removed from thepatient's body, and the wire guide 812 b may remain in place within theceliac artery 880. The position of the wire guide 812 b in the celiacartery 880 may enable delivery of a side branch prosthesis into theceliac artery 880 using any suitable endovascular delivery technique.

Referring now to FIG. 18G, in a next step, the sequence shown in FIGS.18D-18E may be repeated whereby the deployment device 816, or anotherdeployment device, may be introduced via the sheath 810 and the wireguide 812 b in a distal direction from the brachial artery andultimately into the celiac artery 880. The deployment device 816 mayextend out of the distal end 234 of the first branch 230 of theprosthesis 210 so that a side branch prosthesis 830 can be deployed toextend from the first branch 230 into the celiac artery 880. Upondeployment from the deployment device 816, the side branch prosthesis830 and the first branch 230 of the prosthesis 210 may be mated suchthat there is a suitable tromboning connection in the manner describedabove. At this time, the side branch prosthesis 830 may provide patentfluid flow through the graft 212 into the celiac artery 880, and thedeployment device 816, the sheath 810, and the wire guide 812 b may beremoved from the patient's body, as shown in FIG. 18G.

Referring now to FIG. 18H, in a next step, the sheath 810, or anothersheath, and optional dilator may be advanced over the second portion 542b of the auxiliary guide wire 542, in a direction from the brachialartery and distally down the aorta 860. The sheath 810 and optionaldilator may be advanced distally through the lumen 245 of the secondbranch 240, and disposed adjacent to the superior mesenteric artery 879,as depicted in FIG. 18H.

Referring to FIG. 18I, in a next step, the second portion 542 b of theauxiliary guide wire 542 may be retracted distally away from thebrachial artery, such that the most proximal region of the secondportion 542 b of the auxiliary guide wire 542 is positioned at alocation outside of the graft 212 between the distal end 244 of thesecond branch 240 and the distal end 274 of the fourth branch 270. Thewire guide 812 a, or another wire guide, and the catheter 813, oranother catheter, then may be advanced from the sheath 810 in a distaldirection and into the superior mesenteric artery 879 to cannulate thesuperior mesenteric artery 879. The wire guide 812 a may be replacedwith the wire guide 812 b, or another wire guide, and the catheter 813may be removed from the patient's body as described above. Notably, thedistal end 244 of the second branch 240 may accommodate positioning ofthe wire guide 812 a and the catheter 813 since the second portion 542 bof the auxiliary guide wire 542 has been withdrawn from an overlappingrelationship with the second branch 240. The position of the wire guide812 b in the superior mesenteric artery 879 may enable delivery of aside branch prosthesis into the superior mesenteric artery 879 using anysuitable endovascular delivery technique.

Referring now to FIG. 18J, in a next step, the sequence shown in FIGS.18D-18E may be repeated whereby the deployment device 816, or anotherdeployment device, may be introduced via the sheath 810 and the wireguide 812 b in a distal direction from the brachial artery andultimately into the superior mesenteric artery 879. The deploymentdevice 816 may extend out of the distal end 244 of the second branch 240of the prosthesis 210 so that a side branch prosthesis 840 can bedeployed to extend from the second branch 240 of the prosthesis 210 intothe superior mesenteric artery 879. Upon deployment from the deploymentdevice 816, the side branch prosthesis 840 and the second branch 240 ofthe prosthesis 210 may be mated such that there is a suitable tromboningconnection in the manner described above. At this time, the side branchprosthesis 840 may provide patent fluid flow through the graft 212 intothe superior mesenteric artery 879, as shown in FIG. 18J. The deploymentdevice 816, the sheath 810, and the wire guide 812 b then may bewithdrawn proximally out of the patient's body via the brachial artery.

Since the proximal region of the second portion 542 b of the auxiliaryguide wire 542 is now positioned adjacent to the left renal artery 878,as shown in FIG. 18J, the sheath 810, or another sheath, and theoptional dilator then may be advanced over the distal region of thesecond portion 542 b of the auxiliary guide wire 542 in a direction fromthe femoral artery and proximally up the aorta 860. The sheath 810 andthe optional dilator may be advanced distally through the lumen 275 ofthe fourth branch 270 (i.e., proximally relative to the graft 212), andtoward the left renal artery 878 as shown in FIG. 18K. The optionaldilator then may be withdrawn distally out of the patient's anatomy viathe femoral artery, leaving the sheath 810 in place near the left renalartery 878.

Referring to FIG. 18K, with the sheath 810 disposed near the left renalartery 878, the second portion 542 b of the auxiliary guide wire 542 maybe removed distally through the sheath 810, and the wire guide 812 a, oranother wire guide, and the catheter 813, or another catheter, then maybe advanced through the sheath 810 in a proximal direction relative tothe graft 212, distally through the fourth branch 270, and into the leftrenal artery 878 to cannulate the left renal artery 878. The wire guide812 a may be replaced with the wire guide 812 b, or another wire guide,and the catheter 813 may be removed from the patient's body as describedabove. Then, the sequence shown in FIGS. 18D-18E may be repeated wherebythe deployment device 816, or another deployment device, may beintroduced via the sheath 810 and the wire guide 812 b in a proximaldirection from the femoral artery and ultimately into the left renalartery 878. The deployment device 816 may extend out of the distal end274 of the fourth branch 270 of the prosthesis 210 so that a side branchprosthesis 850 can be deployed to extend from the fourth branch 270 intothe left renal artery 878. Upon deployment from the deployment device816, the side branch prosthesis 850 and the fourth branch 270 of theprosthesis 210 may be mated such that there is a suitable tromboningconnection in the manner described above. At this time, the side branchprosthesis 850 may provide patent fluid flow through the graft 212 intothe left renal artery 878, as shown in FIG. 18L. The deployment device818, the sheath 810, and the wire guide 812 b then may be withdrawndistally out of the patient's body via the femoral artery.

The configuration and placement of the various branches 230, 240, 260,270 along the graft 212, together with the self-sealing fenestration250, may provide the ability to manipulate the first and second portions542 a, 542 b of the auxiliary guide wire 542 and the delivery componentsin a manner that will allow for relatively quick delivery of fourdifferent side branch prostheses. The preloaded system provided by thepresent embodiments may save multiple steps and significant time duringa surgical operation.

It will be appreciated that the exact number, orientation, and placementof the various branches and or fenestrations along the graft may bevaried without departing from the spirit of the present embodiments.Moreover, while one exemplary procedure has been described withreference to the thoracoabdominal aorta and its branches, a graft havingmultiple branches and/or fenestrations as described herein may be usedin other procedures, and particularly those that may benefit from apreloaded arrangement to facilitate insertion of delivery componentsinto the various branches and/or fenestrations. Moreover, alternativesystems may include greater or fewer branches, fenestrations, and/orwires than shown herein. For example, in an alternative embodiment, asystem for facilitating deployment of an endoluminal prosthesis mayinclude the graft 212, the first and third branches 230, 260 extendingradially outward from the graft, and a wire extending through the lumensof the first and third branches 230, 260 in the preloaded configuration.The second and fourth branches 240, 270 may be omitted in this example,such that only two branches and one wire segment are provided. Inalternative embodiments, any number of branches, any number offenestrations, and any number of wires may be provided without departingfrom the spirit of the present embodiments.

While various embodiments of the invention have been described, theinvention is not to be restricted except in light of the attached claimsand their equivalents. Moreover, the advantages described herein are notnecessarily the only advantages of the invention and it is notnecessarily expected that every embodiment of the invention will achieveall of the advantages described.

We claim:
 1. A branched prosthesis comprising: a tubular body ofbiocompatible graft material having a proximal end, a distal end, aninternal lumen, and a longitudinal axis from the proximal end to thedistal end; a proximal portion having a first diameter; a distal portionhaving a second diameter less than the first diameter; a tapered portionbetween the proximal portion and the distal portion; a retrograde portalat least partially disposed in the distal portion having an opening andconfigured to permit retrograde fluid flow therethrough; at least twoantegrade portals at least partially disposed in the proximal portioneach having an open end extending toward the distal end and configuredto permit antegrade fluid flow therethrough.
 2. The prosthesis of claim1, wherein the retrograde portal and the at least two antegrade portalsare configured to receive a branch extension.
 3. The prosthesis of claim1, wherein one or more radiopaque markers is positioned proximate to oneor more of the portals to facilitate imaging of the one or more portals.4. The prosthesis of claim 2, wherein the branch extensions are balloonexpandable.
 5. The prosthesis of claim 5, wherein the branch extensionsare covered balloon expandable stents.
 6. The prosthesis of claim 1,wherein the open ends of the antegrade portals are perpendicular to thelongitudinal axis.
 7. The prosthesis of claim 1, wherein the retrogradeportal is circumferentially offset from at least two antegrade portals.8. The prosthesis of claim 1, wherein the proximal portion has aconstant diameter and is stented along its length.
 9. The prosthesis ofclaim 1, wherein the distal portion has a constant diameter and isstented along its length.
 10. A stent graft comprising: a tubular bodyof biocompatible graft material having a proximal end, a distal end, andan internal lumen; a proximal portion having a first diameter; a distalportion having a second diameter less than the first diameter; a taperedportion between the proximal portion and the distal portion and having avariable diameter; two fenestrations in the proximal portion configuredto provide antegrade fluid flow; a fenestration in the distal regionconfigured to provide retrograde fluid flow; wherein the twofenestrations in the proximal portion are configured to receive astented branch graft, and wherein the fenestration in the distal regionis configured to receive a stented branch graft.
 11. The stent graft ofclaim 10, wherein markers radiopaque markers are disposed proximate tothe fenestrations to indicate their positions.
 12. The stent graft ofclaim 12, wherein the antegrade fenestrations are circumferentiallyoffset from the retrograde fenestration.
 13. The stent graft of claim10, wherein the proximal portion has a constant diameter and is stentedalong its length.
 14. The stent graft of claim 10, wherein the distalportion has a constant diameter and is stented along its length.
 15. Amethod of placing a stent graft within a body lumen, the methodcomprising: providing a stent graft disposed on a delivery device, thestent graft comprising a tubular body of biocompatible graft materialhaving a proximal end, a distal end, an internal lumen, a longitudinalaxis from the proximal end to the distal end, a proximal portion havinga first diameter, a distal portion having a second diameter less thanthe first diameter, a tapered portion between the proximal portion andthe distal portion, a retrograde portal at least partially disposed inthe distal portion having an opening and configured to permit retrogradefluid flow therethrough, at least two antegrade portals at leastpartially disposed in the proximal portion each having an open endextending toward the distal end and configured to permit antegrade fluidflow therethrough; delivering the delivery device to a main vessel of apatient; positioning each of the portals within the vicinity of a branchvessel branching from the main vessel; expanding the stent graft withinthe main vessel of the patient; delivering at least one extension branchinto the lumen of the stent graft and through one of the portals; andengaging the at least one extension branch with a branch vessel.